[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibromyalgia-fm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibromyalgia-fm":744},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,47,75,101,126,151,173,210,235,261,286,316,344,375,461,486,513,537,560,584,609,633,651,676,709],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100644668",false,"NCT07674485","AI and Computer Vision-Assisted Telerehabilitation in Fibromyalgia: The FibroIA 2.0 Trial","Effectiveness of Artificial Intelligence- and Computer Vision-Assisted Telerehabilitation, With and Without Resistance Training, on Disease Impact and Physical Function in People With Fibromyalgia: A Randomized Controlled Trial (FibroIA 2.0)","fibroIA 2","Inclusion Criteria:\n\n* Adults aged 18 years or older, of any sex\u002Fgender, with a documented medical diagnosis of fibromyalgia established in primary or secondary healthcare settings according to the American College of Rheumatology (ACR) criteria (Häuser \\& Fitzcharles, 2018).\n* Individuals able to understand and complete the self-report questionnaires used in the study.\n* Individuals with access to a compatible electronic device (smartphone, tablet, or computer) and an internet connection required for participation in the telerehabilitation intervention.\n* Individuals with basic digital literacy skills, defined as the ability to use electronic devices and interact with commonly used applications.\n* Individuals who provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Current participation in another structured therapeutic exercise program, whether supervised or unsupervised.\n* Moderate to severe functional dependence in activities of daily living, defined as a score \\\u003C60 on the Barthel Index.\n* Absolute contraindications to therapeutic exercise, including hypertensive crisis (≥170\u002F110 mmHg), dyspnea at rest, resting tachycardia, or severe glycemic abnormalities (blood glucose \\>250 mg\u002FdL or \\\u003C90 mg\u002FdL in individuals receiving insulin therapy).\n* Severe uncontrolled pain, defined as a score ≥8 on the Numeric Pain Rating Scale (NPRS) at rest.\n* Medical or neurological conditions that significantly limit the safe performance of physical exercise, as determined by clinical assessment.\n* Recent changes in fibromyalgia-specific pharmacological treatment within the previous 4 weeks, to ensure clinical stability throughout the intervention period.","ALL","18 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"NA","Fibromyalgia (FM) is a primary chronic pain condition with an estimated prevalence of 3.3% in Chile. It is characterized by widespread musculoskeletal pain, fatigue, and impaired physical function. Although exercise therapy is considered the first-line intervention, barriers to access and poor adherence limit its effectiveness within the public healthcare system. This study evaluates the effectiveness of an Artificial Intelligence (AI)- and Computer Vision (CV)-assisted telerehabilitation platform called Rehbody. The aim is to determine whether real-time technology-driven feedback can overcome the limitations of traditional face-to-face rehabilitation models by improving disease impact and functional capacity in Chilean patients with fibromyalgia.",[27,28,29],"Fibromyalgia","Fibromyalgia (FM)","Fibromyalgia Syndrome",[31,32,33,34],"fibromyalgia","exercise","telehealth","artificial intelligence","NOT_YET_RECRUITING","2026-06-28",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":21},"2027-01-04",{"date":43,"type":21},"2027-06-21",{"name":45,"class":46},"Instituto Neurociencia Del Dolor","OTHER",{"id":48,"slug":4,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100642752","NCT07648563","Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients","A Monocentric, Randomized, Controlled, No-profit, Interventional Study on the Effects of Forest Therapy in Patients With Fibromyalgia","ForCare","Inclusion Criteria:\n\n* 18 years or older\n* diagnosis of fibromyalgia (diagnosed by a rheumatologist according to ACR criteria)\n* enrolled in the pain management program at the Intensive Care Unit of Cecina Hospital\n* under treatment with painkillers\n* without mobility limitations that prevent them from taking slow, easy walks lasting approximately 2.5 hours and covering approximately 2 km, willing to self-certify their ability to walk unassisted in an obstacle-free environment\n* capable of understanding the purpose of the study and providing informed consent to participate.\n\nExclusion Criteria:\n\n* Patients who have not been diagnosed with fibromyalgia\n* Diagnosis of neoplastic disease\n* Pregnant women\n* Allergies to pollen and\u002For grasses and\u002For insect bites\n* Active systemic disease\n* Neurological disease\n* Degenerative disease\n* Infectious disease",{"count":55,"type":21},70,[24],"The goal of this clinical trial is to evaluate if Forest therapy can reduce pain levels and improve the quality of life related to the level of pain perceived in fibromyalgia patients.\n\nThe main question it aims to answer is:\n\nDoes frequenting certified forest environments, according to the principles and methods of Forest Therapy, produce positive effects on chronic pain and the consumption of painkillers? The study is part of the \"Forest Therapy Project as a Broad-Spectrum Tool for Patients Affected by Fibromyalgia\" funded by the Tuscany Region as part of the Complementary Medicine program for the three-year period 2025-2027. The project will be carried out thanks to the collaboration with the National Research Council - Institute for BioEconomy (CNR-IBE)",[59,28],"Fybromyalgia",[31,61,62,63,64],"forest therapy","pain","painkillers","therapy","2026-06-11",{"date":67,"type":39},"2026-06-15",{"date":69,"type":21},"2026-09-01",{"date":71,"type":21},"2028-08",{"name":73,"class":46},"Azienda USL Toscana Nord Ovest",1,{"id":76,"slug":4,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100643008","NCT07644221","Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia","Transcranial Electrical Stimulation for Noninvasive Study of Pain Circuits in Patients With Chronic Pain","Inclusion Criteria:\n\n* Formal diagnosis of fibromyalgia made by a practicing physician\n* Pain resistant to common analgesics and medications for chronic pain\n* Existing pain for more than 3 months with an average of at least 4 on a 0 to 10 Numerical Rating Scale (NRS)\n* Females of child bearing potential must be at least one of the following totally abstinent from heterosexual intercourse since the last menses before start of study, or agree to concurrent use of at least two methods of birth control throughout study participation.\n\nExclusion Criteria:\n\n* If the subject is non-ambulatory.\n* If the subject is female of child-bearing potential, subject must not be pregnant.\n* Subject must not have a history of brain surgery or uncontrolled neurological conditions, such as seizure, fainting spells, transient ischemic attack.\n* Subject must not have lifetime history of severe, uncontrolled mood disorders (anxiety, depression, bipolar), psychotic disorders, other neural disorders, or heart disease.\n* Subject must not have any implanted electronic or metallic devices.\n* Subject must not have heart diseases, including known arrhythmia, or severe liver or severe gastrointestinal disease or chronic severe infectious disease (e.g. HIV\u002FAIDS).","65 Years",{"count":83,"type":21},50,[24],"The goal of this interventional study is to learn whether noninvasive brain stimulation (NIBS) will have an effect on pain perception in people with fibromyalgia. The main questions it aims to answer are:\n\nDo repeated sessions of NIBS lead to a reduction in perceived pain? Do repeated sessions of NIBS lead to an improvement in quality of life?\n\nResearchers will compare different brain targets to see if effects are different between them.\n\nParticipants will receive repeated daily sessions of NIBS over 4 weeks with application of pressure pain algometry, and complete various questionnaires.",[28],[88,89,27,90,91],"Transcranial Electrical Stimulation","Noninvasive Brain Stimulation","Chronic Pain","Pulsed Transcranial Electrical Stimulation",{"date":93,"type":39},"2026-06-12",{"date":95,"type":21},"2026-06",{"date":97,"type":21},"2027-12",{"name":99,"class":46},"Pulkit Grover",2,{"id":102,"slug":4,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":106,"minAge":18,"maxAge":81,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":4},"100642999","NCT07640607","Investigation of Pain Modulation Phenotypes in Female Patients With Fibromyalgia","Inclusion Criteria:\n\n1. Having received a diagnosis of fibromyalgia according to the 2016 ACR diagnostic criteria\n2. Female patients aged 18-65\n3. Being literate\n4. Having signed the informed consent form upon agreeing to participate in the study\n\nExclusion Criteria:\n\n1. Being under 18 or over 65 years of age\n2. Having any condition that may lower the pain threshold or cause chronic pain (Rheumatoid Arthritis, Ankylosing Spondylitis, systemic inflammatory diseases, malignancies, etc.)\n3. Any neurological condition (stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, central nervous system malignancies…)\n4. Peripheral artery disease\n5. Severe cardiopulmonary insufficiency (stage 3-4)\n6. Uncontrolled systemic diseases such as hypertension and diabetes\n7. Presence of an active infection\n8. Pregnancy\n9. Presence of cognitive impairment, hearing loss, or communication difficulties that would prevent understanding of questionnaires and protocols","FEMALE",{"count":108,"type":21},82,"OBSERVATIONAL","Fibromyalgia is characterized by altered pain processing, including impaired descending pain inhibition and central sensitization. While both mechanisms have been independently associated with disease severity, their interrelationship remains unclear. This cross-sectional study aims to investigate whether central sensitization symptoms mediate the relationship between conditioned pain modulation and fibromyalgia impact.",[28,112,113,114,115],"Quantitative Sensory Testing","Central Sensitization","PRESSURE PAIN THRESHOLD","Pain Perception",[27,117,118],"Pain sensitization","Conditioned pain modulation","2026-06-05",{"date":65,"type":39},{"date":122,"type":21},"2026-06-01",{"date":69,"type":21},{"name":125,"class":46},"Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey",{"id":127,"slug":4,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":74},"100640748","NCT07583056","EEG Prediction and Clinical Efficacy of tDCS in Fibromyalgia.","Clinical Efficacy of tDCS in Fibromyalgia: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors.","FM-TDCS-PREDIC","Inclusion Criteria:\n\n* Patients who meet the diagnostic criteria described by the American College of Rheumatology (Wolfe et al., 2016):\n* Widespread Pain Index (WPI) ≥7 and Symptom Severity Scale (SSS) score ≥5 or a WPI score of 4-6 and SSS ≥9\n* Presence of widespread pain, defined as pain in at least 4 of 5 regions. Jaw, chest, and abdominal pain are not included in the definition of widespread pain.\n* Symptoms have been generally present for at least 3 months.\n* The diagnosis of fibromyalgia (FM) is valid regardless of other diagnoses. The diagnosis of FM does not exclude the presence of other clinically significant diseases.\n* Patients with a stable prescription (or lack thereof) for antidepressant\u002Fpharmacological medication and who agree to continue it throughout the study.\n* Demonstrate the ability to properly administer home-based tDCS independently or with the assistance of a caregiver.\n* Have access to an electronic device with a camera (mobile phone or computer) to allow for monitoring of the intervention and communication with the participant.\n* Have the capacity and willingness to commit to the study team for the completion of all phases of the study.\n* Volunteer to participate and sign the specific informed consent form for this study.\n\nExclusion Criteria:\n\n* Presenting with immune system disorders or comorbidities that explain the main symptoms of fibromyalgia: rheumatoid arthritis, lupus, autoimmune, neurological, and oncological disorders.\n* Presenting with any uncompensated clinical condition such as ischemic heart disease, kidney disease, or liver disease.\n* Presenting with dermatological conditions, such as allergic skin reactions at the electrode sites, psoriasis, etc.\n* Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016):\n* Metallic implants or head injuries, any electronic device such as cochlear implants or cardiac pacemakers.\n* Brain stimulation within the last 6 months.\n* A clinical or family history of epilepsy.\n* Having any structural lesion (for example, any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that could affect safety, participation in the study, or confound the interpretation of the study results, as determined by the investigator.\n* History of drug or alcohol abuse during the study or in the 3 months prior (except for nicotine).\n* Changes in drug treatment in the month prior to starting the trial.\n* Awaiting trial or litigation during the trial.\n* Pregnancy",{"count":134,"type":21},250,[24],"The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with fibromyalgia.\n\nAs complementary goals, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment; and to describe the effectiveness of a high-dose home-based protocol applied to the motor cortex (M1) versus the dorsolateral prefrontal cortex (DLFPC) in patients with fibromyalgia.",[28],[139,27,140,141],"tDCS","EEG","Cost-effectiveness","2026-06-03",{"date":119,"type":39},{"date":145,"type":21},"2026-05-15",{"date":147,"type":21},"2028-06-30",{"name":149,"class":150},"Ionclinics & Deionic SL","INDUSTRY",{"id":152,"slug":4,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100627066","NCT07443800","Comorbidity Between Attention Deficit Hyperactivity Disorder and Fibromyalgia","Comorbidity Between Attention Deficit Hyperactivity Disorder (ADHD) and Fibromyalgia: Cross-prevalence in Patients Treated for ADHD Who Are naïve to Methylphenidate, ADHD Treated With Methylphenidate, or Fibromyalgia, and Associated Metabolomic Factors","HYPERPAIN","Inclusion Criteria:\n\nFor patients with fibromyalgia :\n\n* Men or women aged 18 or over\n* Diagnosis of fibromyalgia\n* Affiliated with a social security scheme\n* Having signed an informed consent form\n\nFor patients with ADHD treated with methylphenidate\n\n* Men or women aged 18 or over\n* ADHD diagnosis\n* Current treatment with extended-release methylphenidate for at least 1 month, with stable dosage for at least 2 weeks\n* Affiliated with a social security scheme\n* Having signed an informed consent form\n\nFor patients with ADHD but not treated with methylphenidate\n\n* Men or women aged 18 or over\n* ADHD diagnosis\n* Affiliated with a social security scheme\n* Having signed an informed consent form\n\nExclusion Criteria:\n\n* For patients with fibromyalgia: existence of another condition explaining chronic pain\n* Severe cognitive impairment\n* Difficulties in understanding self-administered questionnaires\n* Difficulties in assessing pain intensity\n* Acute psychiatric disorder impacting the validity of self-report questionnaire data collection\n* Inability to take biological samples\n* Persons covered by Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in labor, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, persons subject to legal protection measures: guardianship or curatorship).","100 Years",{"count":160,"type":21},100,[24],"The overall objective of the research project presented here is to assess the prevalence of fibromyalgia in patients being treated for ADHD, the prevalence of ADHD in patients being treated for fibromyalgia, and the neurobiological correlates of ADHD-fibromyalgia comorbidity.",[164,28,90],"ADHD - Attention Deficit Disorder With Hyperactivity","2026-06-02",{"date":167,"type":39},"2026-06-04",{"date":38,"type":21},{"date":170,"type":21},"2028-07-01",{"name":172,"class":46},"University Hospital, Tours",{"id":174,"slug":4,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":74},"100620329","NCT07356206","Between Paws and Affections - Impact of Dog-Assisted Therapy in Fibromyalgia Patients","Between Paws and Affections: Impact of Dog Assisted Therapy on Pain, Emotional Symptoms, and Functioning in Fibromyalgia","IDAT26","Inclusion Criteria:\n\n* Age 18 years or older\n* Confirmed diagnosis of fibromyalgia\n* Being followed at ULS Alto Ave by the Multidisciplinary Pain Unit, Internal Medicine (Auto immune diseases), Physical and Rehabilitation Medicine or Neurology\n* Ability to read and write Portuguese and to understand the study procedures\n* Willingness and ability to participate voluntarily in the 10 session program and all scheduled assessments (T1-T4)\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Allergy to dogs or marked fear of dogs\n* History of aggression towards animals\n* History of oncological disease\n* Concomitant systemic or rheumatologic disease that may confound pain and functional assessment\n* Decompensated psychiatric disorder or severe cognitive impairment that may compromise comprehension of the protocol or adherence to the intervention\n* Refusal to participate or withdrawal of consent at any point",{"count":181,"type":21},60,[24],"The purpose of this study is to evaluate the effectiveness and medium-term maintenance of a structured dog-assisted therapy (DAT) protocol, \"Entre Patas e Afetos\" (Between Paws and Affections), in reducing pain, anxiety and depressive symptoms and in improving functional status and quality of life in Portuguese patients with fibromyalgia (FM) followed at ULS Alto Ave, with systematic outcome assessment in the immediate post intervention phase (T2), 6-month follow-up (T3) and 12-month follow-up (T4).",[28],[27,186,187,188,189,190,191,192,193,194,195,196,197,198,199],"Dog-Assisted Therapy","Pain","Anxiety","Depression","Psychoeducation and Relaxation","Fuctional Impact","Catastrophizing","follow-up evaluations","Hospital Anxiety and Depression Scale (HADS)","Pain Catastrophizing Scale","Portuguese Fibromyalgia Impact Questionnaire (FIQ P)","Numerical Rating Scale (NRS)","adapted Wong Baker Faces Pain Scale","Portuguese Brief Pain Inventory - Short Form","RECRUITING","2026-04-28",{"date":203,"type":39},"2026-05-05",{"date":205,"type":39},"2026-01-22",{"date":207,"type":21},"2029-06-30",{"name":209,"class":46},"University of Minho",{"id":211,"slug":4,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":216,"sex":17,"minAge":18,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":74},"100609303","NCT07212829","The Added Value of Transcranial Direct Current Stimulation (tDCS) During Exercise for People With Chronic Widespread Pain","Unravelling the Epigenetic Mechanisms of Exercise-induced Pain in Chronic Widespread Pain: DNA Methylation Regulation of the Brain-derived Neurotrophic Factor Expression and Its Modulation by Transcranial Direct Current Stimulation","Inclusion Criteria:\n\nPatients\n\nParticipants in the patient group must meet all of the following criteria:\n\n1. Diagnosis of chronic widespread pain (CWP) or fibromyalgia;\n2. Age between 18 and 70 years old;\n3. Body mass index (BMI) ≤ 35;\n4. Widespread Pain Index (WPI) assessment: the WPI questionnaire (0-19 points) will be used to record the number and distribution of painful body sites. Participants will be classified as having CWP if pain is reported on both sides of the body, above and below the waist, and in the axial skeleton, with pain symptoms lasting ≥ 3 months;\n5. Stable medication use for at least 1 month prior to study entry.\n\nHealthy control group\n\nParticipants in the healthy control group must meet all of the following criteria:\n\n1. Age between 18 and 70 years old;\n2. Body mass index (BMI) ≤ 35;\n3. No chronic conditions, such as chronic pain and diabetes.\n\nExclusion Criteria:\n\nFor both patients and healthy controls, participants will be excluded if they meet any of the following:\n\n1. Current pregnancy or pregnancy within the past 12 months;\n2. Contraindications for non-invasive brain stimulation (NIBS), in line with published safety guidelines;\n3. History of neurological disorders, including epilepsy (personal or family history), traumatic brain injury, stroke, dementia, or Parkinson's disease;\n4. Major medical conditions, including cancer, endocrine or metabolic disorders, urine, genital and cardiovascu-lar diseases (e.g., myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension).\n5. Substance abuse.\n6. Presence of psychiatric disorders other than depression or anxiety.",true,"70 Years",{"count":219,"type":21},120,[24],"Many people with chronic widespread pain (CWP) feel more pain and fatigue after exercise. This makes it hard to stay active. Unfortunately, the investigators do not fully understand why this happens and how to prevent it.\n\nThe primary goal of this study is to explore the underlying genetic and epigenetic mechanisms of BDNF gene in response to exercise, and investigate if transcranial direct current stimulation (tDCS) during exercise works to improve worsening symptoms response to exercise in people with CWP.\n\nThe investigators designed a randomized crossover study and will enroll 60 patients with CWP and 60 healthy controls. Participants will undergo 2 interventions in random order: 1) exercise + active tDCS, and 2) exercise + sham tDCS. Participants will visit the hospital twice with at least one week in between the visits.",[223,28],"Chronic Widespread Pain",[225,62,32,226],"BDNF","DNA methylation","2026-04-14",{"date":229,"type":39},"2026-04-20",{"date":231,"type":39},"2026-02-01",{"date":147,"type":21},{"name":234,"class":46},"Vrije Universiteit Brussel",{"id":236,"slug":4,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":106,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":74},"100630095","NCT07483216","Effects of a Isokinetic Exercise in Women With Fibromyalgia","Effects of a Microdoses Isokinetic Exercise Protocol in Women With Fibromyalgia","FibrodEx","Inclusion Criteria:\n\n* Women aged ≥ 18 years diagnosed with fibromyalgia according to current clinical criteria.\n* Clinical and pharmacological stability during the weeks prior to participation in the study.\n* Ability to perform supervised exercise and to complete the assessments.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Cardiovascular, neurologic, musculoskeletal or systemic pathology that contraindicate the performance of exercise.\n* Significant change in pharmacological treatment during the period immediately preceding the study.\n* Any condition that, in clinical judgement, prevents them from following the protocol safely.",{"count":243,"type":21},36,[24],"Fibromyalgia is a chronic syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and functional impairment, which significantly affects quality of life. Physical exercise is considered one of the most effective non-pharmacological interventions for the management of this condition; however, uncertainty remains regarding the most appropriate type, intensity, and frequency of exercise for different patient profiles. The aim of this study is to analyze the effects of a microdoses isokinetic exercise program on physical condition, perceived pain, inflammatory profile and quality of life in women diagnosed with fibromyalgia.",[28],[27,248,249,250,187,251],"Exercise","Isokinetic","Microdosing","Non-Pharmacological treatment","2026-04-13",{"date":254,"type":39},"2026-04-16",{"date":256,"type":21},"2026-04",{"date":258,"type":21},"2026-07",{"name":260,"class":46},"European University Miguel de Cervantes",{"id":262,"slug":4,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":270,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":74},"100606478","NCT07176078","Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome","Evaluating the Added Benefit of Osteopathic Care to a Flexi-FODMAP Diet in Fibromyalgia Patients With Irritable Bowel Syndrome: a Randomized Sham-controlled Trial","POISE-IBS-RCT","Inclusion Criteria:\n\nThis study includes participants who meet the following criteria:\n\n1. are over 18 years old;\n2. have a diagnosis of IBS by a medical doctor according to the Rome IV criteria and have an IBS-SSS score of ≥175 (indicating moderate to severe IBS symptoms);\n3. have a medical diagnosis of fibromyalgia or meet the 2016 American College of Rheumatology criteria, characterized by chronic (≥3 months) widespread pain(i.e., a Widespread Pain Index(WPI) score of ≥7 with a Symptom Severity Score of ≥5, or a WPI score of 4-6 with a Symptom Severity Score ≥9 on the Widespread Pain Index).\n\nParticipants will be allowed to use probiotic products and follow a lactose-reduced diet, as long as they kept their usual intake throughout the study, unless a further reduction in lactose was recommended for those assigned to diet therapy. IBS medications, including antidepressants, will be allowed if used consistently at a stable dose for at least 2-3month prior to inclusion. Additionally, participants will need to be willing to adjust their current dietary habits in order to take part in the study.\n\nExclusion Criteria:\n\nThis study excludes participants who meet any of the following criteria:\n\n1. have other gastrointestinal disorders (e.g., inflammatory bowel disease, celiac disease) that could explain the current symptoms;\n2. have diseases affecting gastrointestinal function, including a history of bariatric surgery;\n3. have allergies or food hypersensitivity (other than lactose intolerance);\n4. have any major dietary restrictions or food allergies;\n5. are pregnant or planning pregnancy during the trial (within the next seven months);\n6. have a BMI ≤18 kg\u002Fm²; or 7) have received osteopathic care for IBS and\u002For are already following the FODMAP dietary intervention.",{"count":269,"type":21},96,[24],"Dietary modifications are often recommended as first-line treatment for irritable bowel syndrome, with the FODMAP diet being the most effective intervention to improve global gastrointestinal symptoms. Due to the heterogeneity of symptoms, patients often seek complementary or alternative therapies. This randomized clinical trial aims to determine whether osteopathic care provides additional improvement in gastrointestinal symptoms compared to sham osteopathic care, when both are combined with a flexible FODMAP diet. The trial will also assess the safety and tolerability of osteopathic care.\n\nThe main questions it aims to answer are:\n\nDoes osteopathic care reduce IBS symptom severity more than sham osteopathic care?\n\nDoes osteopathic care improve pain, quality of life, anxiety, fatigue, work productivity, and gut microbiota compared to sham osteopathic care?\n\nDo participants adhere to the flexible FODMAP diet and osteopathic care, and are the effects of osteopathic care maintained at 3- and 6-months post-intervention?\n\nCan pretreatment factors, such as sociodemographic characteristics, IBS severity, predominant symptoms, psychological state, or gut microbiota composition, predict response to osteopathic care?\n\nWhat adverse effects occur with osteopathic care compared to sham care?\n\nParticipants will:\n\nVisit the osteopathy clinic to receive four sessions of real or sham osteopathic care\n\nComplete online assessments before and after the intervention, and at 3- and 6-months post-intervention\n\nProvide stool samples before and after the four osteopathic or sham sessions\n\nKeep a three-day food diary and a ten-day stool diary before and after the intervention, and at 3- and 6-months post-intervention",[273,28],"Irritable Bowel Syndrome (IBS)",[275,276,27,277],"Osteopathic Care","Irritable Bowel Syndrome","FODMAP Diet",{"date":279,"type":39},"2026-04-17",{"date":281,"type":39},"2026-01-01",{"date":283,"type":21},"2027-06",{"name":285,"class":46},"Universitair Ziekenhuis Brussel",{"id":287,"slug":4,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":106,"minAge":18,"maxAge":81,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":314,"locationsCount":74},"100632751","NCT07517757","Dietary Strategies for the Treatment of Fibromyalgia in Overweight and Obese Patients","Impact of Different Dietary Strategies in the Management of Overweight and Obesity in Patients With Fibromyalgia: Effects on Pain, Disease Severity, Nutritional and Metabolic Profile, Gut Microbiota and Microbial Metabolites, and Brain GABA and Glutamate Levels","FIBRODIET","Inclusion Criteria:\n\n* Adult female patients with fibromyalgia, aged ≤ 65 years, who are overweight or obese (BMI 24.9 \\\u003C ≤34.9 kg\u002Fm2);\n* Patients able to independently provide their written informed consent to participate in the study;\n* Patients motivated to participate in the project and able to independently manage the dietary plans provided for in the study.\n\nExclusion Criteria:\n\n* Lack of signature on informed consent form\n* Age \\\u003C 18 and \\> 65 years\n* Male gender\n* Patients with food allergies or celiac disease, type 1 diabetes mellitus and autoimmune forms of diabetes mellitus or with severe pancreatic beta cell dysfunction, undergoing treatment with SGLT2 inhibitors, with recent cardiovascular or cerebrovascular events, liver failure, moderate or severe renal failure, respiratory failure, episodes of gout, kidney stones, electrolyte disturbances, NYHA class III-IV heart failure, unstable angina, cardiac arrhythmias or myocardial infarction within the last 12 months, severe depression or any other psychiatric illness, drug, narcotic or alcohol abuse, frail patients, pregnancy and\u002For breastfeeding, patients about to undergo surgery or invasive procedures, rare diseases (porphyria, carnitine deficiency, carnitine palmitoyltransferase, carnitine acylcarnitine translocase and pyruvate carboxylase, mitochondrial beta oxidation disorders), treatment with diuretics.\n* Use of prebiotics and\u002For probiotics not included in the study, or other dietary supplements in the month prior to enrollment\n* Antibiotic treatment less than 3 months prior to enrollment\n* Infections at the time of enrollment or any chronic gastrointestinal disorder (e.g., Crohn's disease)\n* Significant eating problems (e.g., dysphagia).",{"count":294,"type":21},90,[24],"Spontaneous, non-sponsored, interventional, controlled, randomized, parallel-arm clinical study.\n\nPrimary objective To assess the impact of specific dietary approaches (ketogenic diet, Mediterranean diet, or Mediterranean diet supplemented with GABA-producing probiotics, e.g., Bifidobacterium adolescentis PRL2019) on fibromyalgia (FM) severity-particularly pain, sleep quality, anxiety, and depression-using validated questionnaires in female patients with FM and overweight\u002Fclass I obesity.\n\nSecondary objectives\n\n* Evaluate effects on anthropometric measures, metabolic profile, and body composition.\n* Assess changes in gut microbiota composition and metabolomic analysis.\n* Measure neurosteroids with positive allosteric activity on GABA-A or NMDA receptors in saliva and\u002For plasma.\n* Exploratory pilot sub-study to quantify brain GABA and glutamate levels through magnetic resonance spectroscopy (MRS) in a subset of patients.\n\nMethods Participants will be recruited from the Rheumatology Unit outpatient clinics of IRCCS Policlinico San Martino Hospital (Genoa). Eligible subjects will be adult women with FM and overweight\u002Fobesity, selected through protocol-defined criteria. Enrollment requires written informed consent.\n\nAt enrollment (baseline), participants will complete validated questionnaires assessing FM severity (pain, sleep quality, depression, anxiety, bowel function). Data collection will include sociodemographic information, Mediterranean diet adherence through PREDIMED questionnaire, basal metabolic rate, medical and dietary history, smoking status, blood pressure, and recent laboratory results. Stool, blood, and saliva samples will be collected for routine tests, metabolomics, and ELISA-based measurement of neuroactive steroids like cortisol, progesterone, DHEA.\n\nWithin 7 days T1, results will be reviewed and eligible participants randomized to one of three groups: hypocaloric ketogenic diet, Mediterranean diet, or Mediterranean diet plus probiotics. Individualized dietary plans will be provided with written and verbal instructions.\n\nAnthropometric measurements (weight, height, BMI, waist circumference, waist-hip ratio) and body composition via bioelectrical impedance analysis BIA will be recorded at T0, T4, T8, and T12, together with biological sample collection.\n\nPilot MRS sub-study A subset of participants will undergo brain GABA and glutamate assessment through MRI spectroscopy performed on a 3T Siemens - Prisma magnet at the baseline, before dietary treatment and after 4 weeks. Results will be compared with spectra from control subjects screened through medical history to exclude relevant diseases.",[28],[27,299,300,301,302,303,304,305,306,307],"questionnaires","dietary intervention","obesity","gut microbiota","probiotics","gut-brain-axis","GABA","glutamate","magnetic resonance spectroscopy","2026-04-03",{"date":310,"type":39},"2026-04-08",{"date":256,"type":21},{"date":313,"type":21},"2028-06",{"name":315,"class":46},"Universita degli Studi di Genova",{"id":317,"slug":4,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":326,"conditions":327,"keywords":333,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":74},"100583770","NCT06880653","Dose Response of Exercise for Arthritis Management","Examination of the Dose Response Relationship Between Physical Activity and Arthritis-Attributable Outcomes","DREAM","Inclusion Criteria:\n\n* 18 years or older\n* Have a doctor diagnosed form of arthritis, rheumatoid arthritis, gout, lupus, or fibromyalgia\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have any contraindications to exercise (besides arthritis)\n* Engage in \\>45 min\u002Fweek of Actigraph assessed moderate to vigorous intensity activity\n* Are pregnant, breastfeeding, or planning to become pregnant in the next year\n* Are planning to relocate out of the Columbia, SC area in the next 12 months,\n* Do not have a device compatible with Fitbit\n* Have uncontrolled hypertension (e.g., systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg)\n* Plan to have a surgery that affects mobility in the next 12 months\n* Have a serious cognitive impairment.\n* Not willing to be randomized to any of the 3 conditions, do not believe they could adhere to the goals, or do not believe they could achieve the highest dose of activity (150 minutes\u002Fweek).",{"count":324,"type":21},285,[24],"The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes\u002Fweek, 90 minutes\u002Fweek, or 150 minutes\u002Fweek) on arthritis symptoms.",[328,329,330,28,331,332],"Arthritis","Rheumatoid Arthritis (RA)","Gout","Osteoarthritis","Lupus Erythematosus, Systemic",[334,32,335],"arthritis","physical activity","2026-04-02",{"date":308,"type":39},{"date":339,"type":39},"2025-03-28",{"date":341,"type":21},"2029-04-30",{"name":343,"class":46},"University of South Carolina",{"id":345,"slug":4,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":106,"minAge":350,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":74},"100623999","NCT07403929","The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients","Determination of the Effect of Fermented Grape Juice Consumption on Oxidative Stress and Inflammation Biomarkers and SIRT-1 Levels in Fibromyalgia Patients","Inclusion Criteria:\n\n* Female, 20-40 years\n* BMI 25.0-29.9 kg\u002Fm²\n* FM per 2016 ACR criteria; abdominal pain\u002Fcramp per SSS sub-item\n* MEDAS ≤5 at screening.\n* Willing to maintain habitual activity and comply with assigned intervention; able to provide informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C20 or \\>40\n* BMI ≤24.99 or ≥30.0 kg\u002Fm²\n* Professional athletes; night-shift workers\n* Food allergies; acute infection; antibiotic use within past month or during intervention.\n* Use (past 3 months) of dietary supplements; recent weight-loss or special diets (e.g., ketogenic).\n* Pregnancy\u002Flactation; menopause.\n* Major hepatic\u002Frenal\u002Fcardiac\u002Fimmune disease; chronic GI diseases; diabetes; CNS disorders; cancer; thyroid disease; severe pulmonary disease. Inflammatory arthritis\u002Fautoimmune disease impacting weight; medications including corticosteroids, estrogens, analgesics\u002Fanti-inflammatories, anti-diabetic or lipid-lowering drugs.\n* Severe psychiatric illness\u002Fsubstance use; heavy alcohol\u002Fsmoking.\n* High recent intake of grape juice\u002Fmolasses; excess tea\u002Fcoffee (≥7 cups\u002Fday).\n* Adherence \\\u003C80% to beverage or MNT during run-in\u002Fscreening.","20 Years","40 Years",{"count":353,"type":21},45,[24],"The goal of this clinical trial is to learn if a traditional grape-based fermented drink called hardaliye helps treat fibromyalgia in adult women. We will also learn whether adding hardaliye to a personalized nutrition plan works better than using either one alone.\n\nThe main questions are:\n\nDoes diet + hardaliye improve antioxidant status and lower oxidative stress more than diet only or hardaliye only? Does diet + hardaliye lower inflammation (TNF-α, IL-6, hs-CRP) and raise SIRT1 levels? Do these changes relate to less pain and better symptoms (fibromyalgia impact, gut symptoms, sleep, mood)? Are there benefits for weight, waist size, blood pressure, and blood lipids?\n\nHow the groups are compared:\n\nResearchers will compare three groups for 8 weeks:\n\nDiet + Hardaliye (personalized medical nutrition plan + one 200 mL bottle of hardaliye daily) Diet only (personalized medical nutrition plan) Hardaliye only (usual diet + one 200 mL bottle of hardaliye daily)\n\nParticipants will:\n\nDrink one 200 mL bottle of hardaliye each day if assigned to Diet + Hardaliye or Hardaliye only Follow a personalized nutrition plan if assigned to Diet + Hardaliye or Diet only Visit the clinic at the start and end of the study, with brief check-ins around weeks 2, 4, and 6 Give blood samples before and after the 8-week period Complete short questionnaires on pain, fibromyalgia impact, gut symptoms, sleep, and mood Keep simple logs of daily drink intake and diet plan adherence, and report any side effects\n\nWho can join:\n\nAdult women (20-40 years) with doctor-diagnosed fibromyalgia and BMI 25.0-29.9 kg\u002Fm² who meet the study's health and medication criteria.",[27,28,357],"Fibromyalgia Syndrome, Primary",[31,359,62,360,361,362,363,302,364,365],"chronic pain","inflammation","oxidative stress","sirtuin-1","SIRT1","phytochemicals","nutrition","2026-02-07",{"date":368,"type":39},"2026-02-11",{"date":370,"type":21},"2026-02-15",{"date":372,"type":21},"2027-02-15",{"name":374,"class":46},"Hacettepe University",{"id":376,"slug":4,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":216,"sex":17,"minAge":381,"maxAge":4,"enrollmentInfo":382,"targetDuration":384,"studyType":109,"phases":4,"briefSummary":385,"conditions":386,"keywords":430,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":74},"100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform","2 Years",{"count":383,"type":21},10000,"10 Years","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[387,388,389,390,391,392,393,394,395,396,397,398,399,400,401,402,403,404,405,28,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Autoimmune Encephalitis","Celiac Disease","Celiac Disease in Children","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Autoimmune Diseases","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[406,431,432,433,434,435,436,437,438,439,388,440,441,442,443,444,408,445,446,447,448,449,450,451,452],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Celiac disease","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":205,"type":39},{"date":456,"type":39},"2023-07-05",{"date":458,"type":21},"2030-12-31",{"name":460,"class":46},"Brain Inflammation Collaborative",{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":17,"minAge":468,"maxAge":217,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":471,"conditions":472,"keywords":473,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":74},"100620723","NCT07361328","Personalized Ultrasonic Brain Stimulation for Fibromyalgia","Low-intensity Ultrasonic Neuromodulation for Alleviation of Fibromyalgia Symptoms","BEAMforFMS","Inclusion Criteria:\n\n* Meets American College of Rheumatology criteria for fibromyalgia:\n\n  * Generalized pain, defined as pain in at least 4 of 5 regions, is present.\n  * Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥ 9.\n  * Symptoms have been present at a similar level for at least 3 months.\n  * d.A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses\n* Failure of at least two evidence based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia.\n* Failure of one or more attempts at physical therapy including:\n\n  * Aerobic exercise like walking, cycling, and swimming,\n  * Water therapy\u002Fhydrotherapy with warm water exercises,\n  * Tai Chi involving slow, controlled movements,\n  * Yoga,\n  * Resistance training,\n  * Bodyweight exercises,\n  * Pilates,\n  * Myofascial release therapy applying gentle pressure on trigger points,\n  * Massage therapy,\n  * Trigger point therapy targeting specific pain points,\n  * Joint mobilization,\n  * Postural retraining to correct body alignment,\n  * Balance and coordination exercises,\n  * Feldenkrais method for movement awareness,\n  * Alexander technique to enhance posture and movement efficiency,\n  * Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief,\n  * Heat therapy using hot packs, infrared, or paraffin wax,\n  * Cold therapy with ice packs or cryotherapy,\n  * Ultrasound therapy for deep tissue relaxation,\n  * Biofeedback to control muscle tension and pain response,\n  * Gentle static stretching for prolonged duration,\n  * Active dynamic stretching for full range of motion,\n  * Proprioceptive Neuromuscular Facilitation (PNF) stretching,\n  * Hydrotherapy pool exercises,\n  * Ai Chi (water-based Tai Chi),\n  * Underwater treadmill therapy,\n  * Graded motor imagery (GMI),\n  * Mirror therapy to retrain brain-body connections,\n  * Mindfulness-based stress reduction (MBSR) combining meditation and movement,\n  * Cognitive-behavioral therapy\n  * Gaze stabilization techniques for dizziness and disorientation\n* Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit.\n* Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Baseline visit.\n* Stated willingness and ability to comply with all study procedures, to receive no additional interventions, and to remain on the same psychiatric treatment regimen (e.g., medication, psychotherapy) beginning at least one (1) month prior to screening and for the duration of the main study period unless a change in treatment is recommended or agreed upon by the site principal investigator.\n* For participants of reproductive potential: negative urine or blood pregnancy test at screening; agreement to use a highly effective method of contraception (≤ 1% pregnancy rate) including tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting contraceptives (LARC).\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Any previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder during the participant's lifetime, according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria.\n* Diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5 criteria.\n* Diagnosis of obsessive compulsive disorder and\u002For posttraumatic stress disorder in the past 30 days, according to DSM-5 criteria, and which is unstable in the clinical judgment of the investigator.\n* Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5 criteria.\n* Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5 criteria.\n* Moderate-High Risk of Suicide, according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate Risk), or YES to Question 4, 5, or 6 (High Risk)), or in the clinical judgement of the site principal investigator (PI).","22 Years",{"count":83,"type":21},[24],"The primary purpose of this research is to evaluate a new kind of noninvasive brain stimulation intervention using the investigational ultrasound device, which might be useful for treating fibromyalgia. The device is for investigational use only and is not yet approved by the FDA for the intended use.\n\n* Participants will be asked to visit the study center 7 times for in-person assessment and treatment sessions. In addition, participants will be asked to complete an online assessment 7 times. During in-person or online visits:\n\n  * Participants will undergo an MRI scan twice during the first and last in-person visit (1 hour each) The second MRI may be optional.\n  * There will be 6 treatment sessions (45 minutes each) within a 2-week period\n* The online assessment occurs (15 minutes each)\n\n  * two consecutive days before the first treatment session\n  * 15 days after the first treatment session\n  * 22 days after the first treatment session\n  * 29 days after the first treatment session\n  * 44 days after the first treatment session\n  * 60 days after the first treatment session",[28],[27,474,475,476],"Ultrasound brain stimulation","Clinical trials","MRI","2026-01-15",{"date":479,"type":39},"2026-01-23",{"date":481,"type":39},"2026-01-05",{"date":483,"type":21},"2028-12-31",{"name":485,"class":46},"University of Utah",{"id":487,"slug":4,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":11,"sex":106,"minAge":18,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":74},"100608575","NCT07203339","Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine: Non-inferiority Clinical Trial (FIBROSTIM)","Home-based Transcranial Direct Current Stimulation (tDCS) Compared to Duloxetine in the Treatment of Fibromyalgia: a Randomized Non-inferiority Clinical Trial (FIBROSTIM)","FIBROSTIM","Eligibility Criteria\n\nInclusion Criteria:\n\n* Woman aged between 18 and 75 years\n* Right-handed\n* Literate in reading and writing\n* Clinical diagnosis of fibromyalgia based on the American College of Rheumatology (ACR) 2010-2016 criteria\n* Numeric Pain Scale (NPS) score ≥ 4 on most days in the past 30 days\n* Agree no changes in medication dosage during the treatment period (except for analgesics)\n* Able to swallow tablets\n* Able to understand instructions for using tDCS at home\n\nExclusion Criteria:\n\n* Living more than 250 km from Porto Alegre\n* Pregnancy\n* Decompensated systemic diseases\n* Chronic inflammatory rheumatologic diseases\n* Untreated hypothyroidism\n* Active cancer under treatment\n* Alcohol or drug abuse in the past 6 months\n* Decompensated psychiatric disorders with suicide risk and a defined plan\n* Use of duloxetine at a dose \\> 60 mg\u002Fday\n* Metal implants in the brain\n* Implanted brain medical devices\n* Cardiac pacemaker\n* Cochlear implant\n* Neurological disorders\n* History of traumatic brain injury or neurosurgery","75 Years",{"count":495,"type":21},610,[24],"Fibromyalgia is characterized by widespread pain, fatigue, non-restorative sleep, and psychocognitive alterations, compromising quality of life and leading to absenteeism and early retirement. Up to 70% of patients discontinue treatment with antidepressants and anticonvulsants due to adverse effects or low efficacy, and more than 30% resort to opioid use. Given the treatment challenges and the scarcity of safe alternatives, there is growing interest in interventions such as transcranial direct current stimulation (tDCS), which has shown efficacy in improving symptoms and functionality, with low cost and few side effects. In this context, we designed a randomized, double-blind, double-dummy clinical trial to compare the non-inferiority of 28 home-based anodal tDCS (2 mA) applied over the primary motor cortex (M1) versus duloxetine 60 mg. Both treatments will be combined with physical exercise and pain education. Outcomes will be assessed through multidimensional measures of pain, functionality, global impression of improvement, and the function of the descending pain inhibitory system. Secondary outcomes include quality of life, depressive symptoms, psychophysical pain measures, and treatment adherence. An additional analysis will compare the results of sham tDCS and duloxetine placebo within the non-inferiority model. Predictors of treatment response will also be explored, including symptom severity and oscillatory patterns of cortical electrical activity, rest-activity rhythm, and autonomic function assessed by R-R interval. Furthermore, serum levels of S100-B protein, brain-derived neurotrophic factor (BDNF), and genetic variants related to neuroplasticity in the BDNF Val66Met, Catechol-O-Methyltransferase (COMT) (rs4680) (G\\>A), OPRM1, and PER2 genes will be analyzed. Inflammatory markers (TNF-α, IL-1, IL-2, IL-6, IL-10, C-reactive protein) and serum endorphins will also be assessed. A total of 610 women with fibromyalgia (aged 18 to 75 years) will be randomized into three groups (2:2:1): duloxetine + sham tDCS (n=244); active tDCS + placebo (n=244); and sham tDCS + placebo (n=122). Participants will be assessed during treatment and at 3, 6, and 12 months after completing the intervention protocol. An interim analysis will be conducted when \\~50% of participants (n ≈ 305) complete the 3-month follow-up by an independent, blinded Data Monitoring Committee (DMC). (i) The trial may be stopped if the conditional probability of demonstrating non-inferiority is \\\u003C10%, based on frequentist or Bayesian methods. (i) The trial will be stopped if serious adverse events (SAEs) in the active tDCS group increase by ≥30% compared to duloxetine (p \\\u003C 0.01, adjusted). (ii) Early stopping for efficacy will be considered if active tDCS demonstrates clear non-inferiority or superiority over duloxetine on the primary outcome. Superiority requires: (iii) a clinically relevant difference exceeding the non-inferiority margin (≥10% pain reduction); (ii) statistical significance (p \\\u003C 0.005, O'Brien-Fleming adjusted); and (iii) a ≥2-point (20%) improvement on the BPI, confirmed in the ITT analysis. This study aims to generate evidence to support the decision-making process of the National Committee for Health Technology Incorporation (CONITEC) regarding the availability of tDCS in the Brazilian Unified Health System (SUS). In addition, identifying predictors of response to tDCS and duloxetine, through the integration of genetic, neurophysiological, inflammatory, and psychosocial markers using machine learning algorithms, will allow for identifying factors that can personalize fibromyalgia treatment. This approach enhances clinical efficacy, reduces costs associated with ineffective interventions, and supports more accurate therapeutic decisions, expanding access to safe, effective, and sustainable care within the public healthcare system",[28,139,499,225,140],"Duloxetine",[27,501,499,502,503],"Transcranial Direct Current Stimulation","Biomarkers","Precision Medicine","2025-12-31",{"date":506,"type":39},"2026-01-06",{"date":508,"type":39},"2025-09-30",{"date":510,"type":21},"2028-12",{"name":512,"class":46},"Hospital de Clinicas de Porto Alegre",{"id":514,"slug":4,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":106,"minAge":18,"maxAge":81,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":534,"leadSponsor":535,"locationsCount":74},"100617790","NCT07323199","Exercise and Neuromodulation in Fibromyalgia","High-Intensity Interval Training (HIIT) and Transcranial Direct Current Stimulation (tDCS) in Women With Fibromyalgia - Effects on Clinical and Neuro-physiological Variables: Randomized Clinical Trial Protocol","Inclusion Criteria:\n\n* Women with a diagnosis of Fibromyalgia by a physician according to the criteria of the American College of Rheumatology (ACR) 2016\n* A stable medical treatment for symptoms for at least 4 weeks before participation (stable doses of medication)\n* Reported pain equal to or higher than 40 mm on the visual analogue scale (moderate or severe pain) for more than 3 months\n* Body mass index (BMI) between 18.5 and 39.9 kg m-2,\n* Controlled high blood pressure.\n\nExclusion Criteria:\n\n* Isolated inflammatory joint, cancer, infectious, traumatic, localised neuropathic or degenerative joint pain.\n* Intense headache, cerebral surgery, seizure\u002Fepilepsy, cardiovascular, lung, metabolic (II diabetes mellitus), retinopathy or neurological diseases (i.e. stroke and traumatic brain injury antecedents),\n* Severe psychiatric disorders, major depression\n* Substance abuse.\n* Currently pregnant\u002Fbreastfeeding,\n* Under physical therapy treatment or have participated in a designed sports or exercise training in systematic programs in the last 3 months.\n* Unable to speak or read Spanish fluently (inability to understand the pain scale and cooperate in testing)",{"count":520,"type":21},40,[24],"Exercise is recommended for people with fibromyalgia because it can reduce symptoms and improve quality of life. Some studies show that high-intensity exercises like running or cycling (also called high-intensity interval training, or HIIT) may reduce symptoms more effectively than slower, traditional exercises.\n\nThere are also new treatments, like non-invasive neuromodulation, which uses a gentle current to stimulate brain cells. This technique can help reduce pain in people with fibromyalgia. However, we don't yet know if combining HIIT and neuromodulation works better than exercise alone. We also want to find out if this combination helps improve other symptoms like fatigue and poor sleep.\n\nThe goal of this study is to see how a combination of HIIT and neuromodulation affects pain, fatigue, sleep, and muscle strength in women with fibromyalgia.\n\nThe investigators are asking two main questions:\n\nDoes combining HIIT and neuromodulation reduce pain better than exercise alone? Does this combination improve how the brain controls pain, muscles, and other symptoms like fatigue and sleep problems? What Will the Study Involve?\n\nThree different exercise training programs will be compared:\n\nHIIT with neuromodulation (tDCS): The participant will do HIIT by cycling at a high intensity for 1 minute, then resting for 2 minutes. Then, this will be repeated 10 times. At the same time, the researchers will place two small, damp sponges on the head of the participant. These sponges connect to the tDCS device, which sends a gentle current to your brain. It might feel a tingling sensation at first, but it will fade away.\n\nHIIT with a \"sham\" (inactive) neuromodulation: This is similar to the first program, but the tDCS device will only be active for a few minutes at the beginning and end of the session.\n\nHIIT alone: This involves just the cycling exercise with no brain stimulation. Who Can Participate?\n\nThe researchers are looking for women who:\n\nAre 18-65 years old and have been diagnosed with fibromyalgia Experience moderate to high levels of pain Have stable blood pressure (if they have hypertension) Are not regularly active (don't do more than 30 minutes of exercise at least 3 times per week)\n\nWhat Will the Study involve?\n\nThe participant will:\n\nAttend 6 conditioning sessions (cycling) over two weeks to prepare their body. Complete 4 weeks of HIIT training, three times per week, at Universidad Andres Bello.\n\nAttend 3 assessment sessions in our lab: before the conditioning, before the training, and after the training. These will include:\n\nNon-invasive tests to measure your physical fitness, muscle strength, and pain sensitivity Brain and muscle connection tests. Questionnaires about your sleep, pain, fatigue, anxiety, depression, and exercise enjoyment\n\nWhat the participant will get?\n\nAt the end of the study in addition to the training benefits, participants will receive a detailed report showing their body composition (muscle and fat levels) before and after the training.",[28],[27,525,187,526,527,528,529],"central sensitization","intracortical excitability","HIIT - HIGH-INTENSITY INTERVAL TRAINING","tDCS - transcranial direct stimulation","transcranial magnetic stimulation","2025-12-26",{"date":532,"type":39},"2026-01-07",{"date":281,"type":21},{"date":283,"type":21},{"name":536,"class":46},"Universidad Nacional Andres Bello",{"id":538,"slug":4,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":74},"100614653","NCT07282392","Helping Lupus Patients Manage Fibromyalgia Symptoms Through Emotional Awareness and Expression Therapy (EAET)","Evaluating the Feasibility and Efficacy of Emotional Awareness and Expression Therapy (EAET) on Fibromyalgia Outcomes in Patients With Systemic Lupus Erythematosus (SLE).","EAET","Inclusion Criteria:\n\n* Adults of all genders, ages 18-65.\n* A diagnosis of lupus and fibromyalgia or chronic widespread pain by a licensed rheumatologist\n* Be on a stable medication regimen.\n\nExclusion Criteria:\n\n* Serious psychiatric disorders (e.g., schizophrenia or bipolar disorder) uncontrolled with medications.\n* Active suicidal ideation.\n* Untreated alcohol or substance use disorder.\n* Substantial cognitive impairment.\n* Changes in medications in the past 3 months.\n* Enrollment in another treatment study.\n* Current involvement in health-related litigation or disability application.\n* Inability to use a computer and\u002For smartphone.\n* limited access to the internet.\n* Inability to communicate in English.\n* Failure to complete the baseline assessments.",{"count":545,"type":21},30,[24],"The goal of this clinical trial is to learn if a psychotherapy intervention works to relieve widespread pain in patients with lupus. The main questions it aims to answer are:\n\nIs the psychotherapy treatment safe for lupus patients? Are lupus patients able to complete the treatment? Can the treatment help improve chronic pain and other symptoms in lupus patients?\n\nResearchers will compare the treatment to a control (participants who will continue their medical treatment but will not receive psychotherapy for the time frame of the treatment) to see if the psychotherapy treatment works to relieve widespread pain and other lupus-related symptoms.\n\nParticipants will:\n\nFill out questionnaires before and after the treatment. Participate in 8 weekly treatment sessions, 2 hours per session, delivered via Zoom from their own home.\n\nKeep a list of medications and monitor any changes in their medication regimen.",[407,28,223],[550,31,551],"lupus","chronic widespread pain","2025-12-19",{"date":554,"type":39},"2025-12-29",{"date":556,"type":39},"2025-12-01",{"date":558,"type":21},"2028-11-04",{"name":485,"class":46},{"id":561,"slug":4,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":572,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":74},"100615527","NCT07293767","Silymarin vs Hesperidin\u002FDiosmin in Fibromyalgia","The Effect of Silymarin Versus Hesperidin\u002FDiosmin Combination on Patients With Fibromyalgia","SHD-FM","Inclusion Criteria:\n\n* Informed written consent.\n* Participant must meet the American College of Rheumatology 2016 revised classification criteria for Fibromyalgia: Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI 3 to 6 and SS scale score ≥ 9\n* Age \\>18 years old (males and females)\n* Diagnosis of FM confirmed by a rheumatologist.\n* Persistent pain syndrome on conventional therapy.\n* Not taking Daflon or Legalon for 6 months.\n\nExclusion Criteria:\n\n* Pain due to other conditions (e.g. diabetic peripheral neuropathic pain or post-herpetic neuralgia) that would confound assessment or self-evaluation of the pain associated with FM.\n* Patients with pain due to any widespread inflammatory musculoskeletal disorder (e.g. rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.\n* Allergy to silymarin or diosmin or hesperidin.\n* Cognitive deficits that could impair understanding of the study, completion of questionnaires, or adherence to therapy.\n* Pregnant or planning pregnancy women and breastfeeding women.\n* Major comorbidities like renal impairment, severe liver disease, chronic hepatitis C, history of alcohol or drug addiction.\n* Current severe or uncontrolled major depressive disorder or anxiety disorders.\n* Patients will be excluded if there is no compliance to the medication.","60 Years",{"count":294,"type":21},[24],"Fibromyalgia is a chronic disease, characterized by chronic widespread pain, physical exhaustion, sleep problems, and unexplained pain in both joints and muscles. Fibromyalgia's causes still unknown, but there are various risk factors that can cause fibromyalgia such as genetic causes, physical shock, and infections. Fibromyalgia typically presents in young or middle aged females, it occurs in females more than males, and it is characterized with widespread pain throughout the whole body in both sides such as arms, shoulders, head, and abdominal areas. The etiology of fibromyalgia still unclear, but there are several factors such as alterations in the sleep pattern, changes in the neuroendocrine transmitters such as cortisol, growth hormones and serotonin, dysfunction of central and autonomic nervous systems, psychiatric aspects and external stressors . The pain seems to result from neurochemical imbalances in the central nervous system that lead to a \"central amplification\" of pain perception characterized by allodynia (a heightened sensitivity to stimuli that are not normally painful) and hyperalgesia (an increased response to painful stimuli). this interventional study aims to study effect of silymarin and hesperidin\u002Fdiosmin combination on fibromyalgia patients and compare their effect with control patients on the following\n\n1. Management of pain.\n2. Inflammatory biomarkers.\n3. Quality of life.",[28],[31,573,574,575],"silymarin","hesperidin","diosmin","2025-12-07",{"date":552,"type":39},{"date":579,"type":39},"2024-11-16",{"date":581,"type":21},"2026-12-31",{"name":583,"class":46},"Ain Shams University",{"id":585,"slug":4,"hasResults":11,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":11,"sex":106,"minAge":18,"maxAge":81,"enrollmentInfo":591,"targetDuration":4,"studyType":22,"phases":593,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":74},"100612998","NCT07260864","Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia","Investigating the Differential Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Left and Right Motor Cortex in Fibromyalgia: A Prospective Randomized Trial With Functional Magnetic Resonance Imaging (MRI(","rTMS","Inclusion Criteria:\n\n* Female aged 18 to 65, right-handed, with no racial\u002Fethnic restrictions.\n* A diagnosis of fibromyalgia by a qualified physician according to the American College of Rheumatology 2016 criteria\n* Must have a history of fibromyalgia pain for a duration ≥ 3 months, as it is included in the diagnostic criteria.\n* Must have pain intensity equal or greater than 4\u002F10 on the numerical rating scale (NRS) at enrollment.\n* Concurrent chronic overlapping pain conditions (except migraine with aura), depression, and anxiety will be allowed when mild to moderate (Less than 31 on Beck Depression Inventory or less than 36 on Beck Anxiety Inventory), except in cases with psychotic or manic features.\n* Concomitant medication (except tricyclics, antipsychotic medications, bupropion, methadone, theophylline) and their doses for mood, pain and sleep disorders must be steady at least 4 weeks before enrolment and must be kept at a steady dosage during the trial.\n* Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires.\n* Must be in generally stable health.\n* Must sign an informed consent document after explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Age outside the studied range (i.e., \\\u003C 18, \\> 65).\n* Patients planning to change their medications during trial.\n* Participants who are currently receiving other alternative therapies during trial (e.g., physiotherapy, acupuncture).\n* History of receiving TMS, transcranial direct current stimulation (tDCS), or electroconvulsive therapy (ECT).\n* Evidence of rheumatologic disorders, autoimmune diseases, taking immunosuppressive treatment, severe or unstable cardiac diseases.\n* Fibromyalgia must be the primary complaint; hence patients cannot have another main source of pain (e.g., osteoarthritis). Patients will be asked to shade all the areas in which they experience pain on a body map. If they shade areas other than typical fibromyalgia pain, we will discuss any previous diagnosis, the intensity and chronicity of pain, and exclude them if chronic pain in any area outside the condition in to be studied is confirmed.\n* Involvement in litigation regarding their pain or having a disability claim or receiving workman compensation or seeking either because of their pain.\n* Any history of hemorrhagic or thrombotic stroke.\n* History of schizophrenia, schizoaffective disorder, bipolar disorders, mania, hypomania, eating disorders, or any psychiatric illness with psychotic features (major depressive disorder, mild to moderate without psychosis, or anxiety disorders are not exclusion criteria).\n* Current use of tricyclic antidepressants or any antipsychotic medications, given the risk of seizure incidence independent of TMS use in tricyclics is up to 0.4% or second-generation antipsychotics up to 1.2%.\n* Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, sleep apnea, or malignancy. Stable diabetes mellitus, stable hypertension (meaning that these conditions are followed up on by a physician and they are getting treatment for it with clinical stability), or hyperlipidemia are not exclusion criteria.\n* History of traumatic brain injury\n* History of epileptic disorders or family history of seizures in first degree relatives\n* History of syncope\n* History of tinnitus or hearing loss\n* Current or history of substance misuse\u002Fdependence including alcohol at time of entry into the study.\n* History of COVID-19 infection with persistent neurologic symptoms.\n* Intra-axial implants (e.g., spinal cord stimulators or pumps) that are MRI incompatible.\n* All exclusion criteria for MRI and TMS safety: any metallic implants, chips, or plates, cochlear implants, brain or skull abnormalities, aneurysm clips or coils, non-removable piercings, tattoos containing ferromagnetic ink, and claustrophobia.\n* Surgery within the past 3 months or history of any brain surgery\n* Pregnancy\n* Participation into another research study\n* In the judgment of the investigator, unable or unwilling to follow the protocol and instructions.",{"count":592,"type":21},20,[24],"The first goal of this study is to see how brain activity changes in people with fibromyalgia after they get a treatment called rTMS (repetitive transcranial magnetic stimulation). Researchers are looking at how the parts of the brain that control movement (called motor cortices) respond to this treatment.\n\nThe second goal is to find out if the changes in brain activity are different between the right and left sides of the brain, depending on which side gets the treatment.",[28],[597,90,598,599,600],"Transcranial Magnetic Stimulation","Nociplastic pain","Functional Magnetic Resonance Imaging","Motor Cortex",{"date":602,"type":39},"2025-12-03",{"date":604,"type":21},"2025-12-30",{"date":606,"type":21},"2026-09-30",{"name":608,"class":46},"University of Rochester",{"id":610,"slug":4,"hasResults":11,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":27,"eligibilityCriteria":614,"healthyVolunteers":216,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":615,"targetDuration":617,"studyType":109,"phases":4,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":630,"leadSponsor":631,"locationsCount":74},"100578596","NCT06813352","Analysis of Facial Expressions for Pain Recognition in Fibromyalgia: Using Artificial Intelligence and Biomarkers","Analysis of Facial Expressions for Pain Recognition: Using Artificial Intelligence and Biomarkers as a Pain Diagnostic Tool in Fibromyalgia, a Pilot Study","Inclusion Criteria:\n\n* The inclusion criteria are patients with no diagnosed cognitive deficit and who are willing to take part in the study.\n\nExclusion Criteria:\n\n* Exclusion criteria are patients who use medication that can affect anxiety or depression or inability to understand the instructions.",{"count":616,"type":21},122,"1 Day","Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome with characteristics of generalized body pain, low pain threshold, tenderness and stiffness in muscles, tendons and joints. The assessment of pain in this condition is a challenge due to its subjective nature. A promising approach to assessing pain intensity is facial expression analysis, which can serve as an objective indicator. In addition, research seeks to identify molecular molecular markers to quantify pain. However, the lack of a standardized system has made it difficult to identify reliable markers. In summary, the search for objective methods of assessing pain in fibromyalgia is essential in order to develop more effective more effective treatments. Facial expression analysis and the investigation of molecular markers are promising ways of quantifying pain intensity more accurately and intensity of pain more accurately and reliably in fibromyalgia.",[28,187,620],"Catastrophizing Pain",[27,622,623,624,625],"Artificial intelligence","Molecular biomarkers","Catastrophism","Facial expression","2025-11-17",{"date":628,"type":39},"2025-11-19",{"date":626,"type":39},{"date":69,"type":21},{"name":632,"class":46},"Faculdade de Ciências Médicas de Minas Gerais",{"id":634,"slug":4,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":639,"targetDuration":4,"studyType":22,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":647,"leadSponsor":649,"locationsCount":4},"100599895","NCT07090434","Effect of Bei App for Fibromyalgia","Effect of an mHealth-based Digital Intervention to Support Multimodal Treatment in Patients With Fibromyalgia.","Inclusion Criteria:\n\n* Participants will be adults between 18 and 65 years of age with a clinical diagnosis of fibromyalgia according to the 2016 criteria established by the American College of Rheumatology (ACR).\n* All participants must be actively enrolled in the group sessions offered by the patient association and possess the ability to use a smartphone or tablet compatible with the BEI app.\n* Informed consent must be provided voluntarily.\n* Additionally, participants are required to have a minimum level of digital health literacy, operationalized as a score equal to or greater than 2.5 in at least four dimensions of the eHealth Literacy Questionnaire (eHLQ).\n\nExclusion Criteria:\n\n* Participants will be excluded if they present with severe or unstable psychiatric disorders, such as schizophrenia or uncontrolled major depression.\n* Other exclusion criteria include medical comorbidities that contraindicate physical activity, current pregnancy, or concurrent participation in another digital health program or the use of similar therapeutic applications.\n* Individuals with cognitive impairments or technological limitations that prevent the use of the app or participation in digital assessments will also be excluded.",{"count":55,"type":21},[24],"Background: Fibromyalgia (FM) is a complex, chronic condition characterized by widespread musculoskeletal pain, cognitive dysfunction, fatigue, and emotional comorbidities such as anxiety and depression. These symptoms severely impact daily functioning and quality of life. Although non-pharmacological strategies-such as therapeutic exercise and patient education-are recommended as first-line treatments, their implementation outside the clinical setting remains a challenge due to low adherence and lack of continuity. Objective: To evaluate the effectiveness of a digital health intervention-BEI app-as a complement to usual care in improving clinical and functional outcomes among patients with fibromyalgia. Methods: This is a randomized controlled trial (RCT) with two parallel arms (1:1 allocation). A total of 70 adult participants with fibromyalgia (diagnosed per ACR 2016 criteria) will be recruited through a patient association in Madrid, Spain. The control group will receive 12 weeks of standard, in-person treatment consisting of group-based education and physical activity. The experimental group will receive the same in-person program plus daily access to the BEI mobile application, which includes educational modules, physical and cognitive training, symptom tracking, and personalized feedback. Outcomes will be assessed at baseline, week 6 (mid-intervention), week 12 (post-intervention), and week 24 (follow-up). Primary outcomes include pain intensity (VAS) and functional impact (FIQR). Secondary outcomes include catastrophizing, self-efficacy, cognitive function, physical activity, anxiety, depression, quality of life, app engagement, and satisfaction. Expected results: The results of this trial will provide evidence regarding the potential of mHealth tools to enhance adherence, self-efficacy, and functional outcomes in individuals with fibromyalgia.",[28],"2025-07-24",{"date":645,"type":39},"2025-07-29",{"date":532,"type":21},{"date":648,"type":21},"2027-06-30",{"name":650,"class":46},"Universidad Autonoma de Madrid",{"id":652,"slug":4,"hasResults":11,"nctId":653,"briefTitle":654,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":216,"sex":17,"minAge":18,"maxAge":657,"enrollmentInfo":658,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":659,"conditions":660,"keywords":662,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":4},"100592369","NCT06992531","Auto-immune Contribution in Symptom-based Sensory and Autonomic Disorders","ACSSAD","Inclusion Criteria:\n\n* Between 18 and 80 years of age.\n* In the capacity to understand and sign an Informed Consent Form.\n* Willing and able to comply with scheduled visits and study procedures.\n* Diagnostic criteria for participants:\n* PoTS: following Heart Rhythm Society Expert Consensus Statement criteria, 2015, with or without comorbid FMS.\n* FMS: following the American College of Rheumatology criteria 2016, with Fibromyalgia Impact Questionnaire (FIQ) exceeding 50, and with an average pain intensity exceeding 5.5.\n* Healthy volunteers: no diagnosed autoimmune, chronic pain, or dysautonomia condition.\n\nExclusion Criteria:\n\n* Previous diagnosis of an established autoimmune condition or dermatological conditions affecting skin afferents (e.g. psoriasis, lupus, vitiligo, dermatitis…).\n* Application of local anaesthetics or steroid injections within 35 days prior to the microneurography visit.\n* Current use of anticoagulant therapy.\n* History of peripheral neuropathy or conditions usually associated with peripheral neuropathy, such as Diabetes Mellitus, Vitamin B12 deficiency, Lyme disease, a screen positive for hepatitis B surface antigen, hepatitis C virus antibody, or antibodies against human immunodeficiency viruses 1 and 2.\n* Pregnancy.\n* Difficulties in locating the nerve (i.e. nerve cannot be seen or palpated) or previously known trauma or surgery in the area innervated will be a criterion for the exclusion of the participant for this part of the study.\n* History of regular alcohol consumption (exceeding 14 units per week) or recent alcohol consumption exceeding 14 units per week over the last 6 months (14 units is equivalent to 7 pints \\[568 mL\u002Fpint\\] of beer at 3.6% alcohol by volume or 6 standard glasses \\[176 mL\u002Fglass\\] of wine at 12% alcohol by volume).\n* Excessive consumption of caffeinated beverages (e.g., coffee, tea, cola, energy drinks), is defined as greater than 6 servings per day (1 serving\u002F236 mL equals approximately 120 mg of caffeine).\n* A history of drug abuse or addiction within 2 years before study, current regular or recreational use of marijuana (or any cannabis derivative).","80 Years",{"count":134,"type":21},"Postural Orthostatic Tachycardia Syndrome (PoTS) is a condition where the heart rate increases when standing up, causing symptoms like dizziness and fainting. It primarily affects young women and can be very disabling, impacting daily life. In addition to the typical symptoms related to standing, people with PoTS also experience unexplained pain and fatigue, which worsen their quality of life. The exact causes of PoTS are still unknown, but it is often triggered by viral infections and some PoTS patients show signs of immune system involvement, such as the presence of certain autoantibodies and other autoimmune conditions. Research on other chronic pain disorders, including fibromyalgia syndrome (FMS), has found that autoantibodies can cause pain by affecting how the nerves work. This study aims to investigate if similar immune-related mechanisms are behind the widespread pain seen in PoTS. This study will also look at how PoTS affects the nervous system by testing nerve activity in participants and assessing the number of nerve fibres in the skin, to check if similar changes can be seen in mice. This study will also involve participants with fibromyalgia syndrome and healthy volunteers.",[661,28],"Postural Orthostatic Tachycardia Syndrome (POTS)",[663,29,664,665,666],"Postural orthostatic Tachycardia Syndrome","Widespread pain","Autoantibodies","Autonomic and sensory functions","2025-05-27",{"date":669,"type":39},"2025-05-28",{"date":671,"type":21},"2025-10",{"date":673,"type":21},"2030-10",{"name":675,"class":46},"King's College London",{"id":677,"slug":4,"hasResults":11,"nctId":678,"briefTitle":679,"officialTitle":680,"acronym":681,"eligibilityCriteria":682,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":683,"targetDuration":4,"studyType":22,"phases":685,"briefSummary":686,"conditions":687,"keywords":688,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":703,"completionDateStruct":705,"leadSponsor":707,"locationsCount":74},"100587004","NCT06922747","FIBROmyalgia: Somatic Tracking and Exercise Program Study","FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia","FIBROSTEPS","Inclusion Criteria:\n\n* Diagnosed with fibromyalgia according to the criteria specified in Wolfe et al (2016)\n* Able to perform light physical activity\n* Able to provide written informed consent\n* Owning a smartphone\n* Able to be followed for 24 weeks\n\nExclusion Criteria:\n\n* Pregnant\n* Severe co-morbid psychiatric or neurological disorders\n* Current participation in another clinical trial\n* Recent surgery or other physical constraints preventing exercise",{"count":684,"type":21},200,[24],"The goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. The participant group will be people with fibromyalgia in age group 18-65 years. The two interventions to be tested over sixteen weeks are:\n\n* weekly exercise sessions in groups\n* weekly consultations with a therapist\n\nThe main question it aims to answer is: Is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia?\n\nParticipants will wear Fitbit activity trackers, register pain intensity daily on a mobile app, and answer the Fibromyalgia Impact Questionnaire (FIQ). They will be divided into four groups:\n\n* one group receiving the exercise intervention\n* one group receiving the psychological intervention\n* one group receiving both intervention\n* one control group recieving general physical activity recommendations\n\nBefore the sixteen weeks intervention period, there will be a baseline period of eight weeks. Durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle.\n\nResearchers will compare the combination of the interventions against only one intervention and the control group.",[28,27,29],[689,690,691,692,693,335,694,695,31,62,696,697,698,699],"fibromyalgia impact questionnaire","randomized controlled trial","clinical trial","factorial design","2*2 factorial design","somatic tracking","activity","effect study","musculoskeletal pain","rheumatic diseases","musculoskeletal diseases","2025-05-07",{"date":702,"type":39},"2025-05-13",{"date":704,"type":21},"2027-01",{"date":706,"type":21},"2028-01",{"name":708,"class":46},"University of Tromso",{"id":710,"slug":4,"hasResults":11,"nctId":711,"briefTitle":712,"officialTitle":713,"acronym":714,"eligibilityCriteria":715,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":716,"enrollmentInfo":717,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":719,"conditions":720,"keywords":730,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":737,"lastUpdatePostDateStruct":738,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":742,"locationsCount":100},"100590434","NCT06967363","Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)","Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Brain Function in Low Back Pain Patients: a Longitudinal Cohort Study","LBPB","Inclusion Criteria:\n\n1. Adults aged 18 to 80 years.\n2. Diagnosis of low back pain, defined as pain located between the lower costal margins and the gluteal folds, with or without leg pain.\n3. Eligible for surgical or non-surgical treatments.\n4. Willingness to undergo neuroimaging (fMRI), microbiota sampling, psychological assessments, and other related study procedures. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Severe neurological deficits requiring emergency surgery.\n2. Antibiotic or probiotic use within the past 4 weeks. Suffering from digestive diseases such as irritable bowel syndrome, gastric ulcer, duodenal ulcer, etc.;\n3. Diagnosed spinal infections, tumors, fractures, or inflammatory diseases (e.g., ankylosing spondylitis).\n4. Known severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that would interfere with study participation.Head trauma; history of substance abuse.\n5. Contraindications to MRI scanning (e.g., pacemaker, metallic implants, severe claustrophobia).\n6. Pregnant or breastfeeding women.\n7. Participation in another interventional clinical trial within the past 3 months.\n8. Working at night shifts or travelling across time zones in the past 6 months.\n9. Excessive consumption of coffee, tea.","85 Years",{"count":718,"type":21},360,"This prospective cohort study investigates the neurobiological, genetic, and psychosocial mechanisms underlying acute and chronic low back pain (LBP). Core objectives include establishing a high-quality biobank to support future research in connectomics, genomics, and biomarker discovery, and identifying predictors of pain progression and treatment response.\n\nThe study will also assess the impact of comorbid conditions such as anxiety, depression, and sleep disturbances on pain perception and clinical outcomes. Longitudinal analyses will explore the dynamic interplay between emotion, cognition, sleep, and pain to inform precision, mechanism-based interventions.\n\nFunctional imaging will be used to examine brain responses to nociceptive modulation, aiming to identify neural circuits involved in pain chronification. By integrating multimodal data-including neuroimaging, neurophysiology, microbiota profiling, polysomnography, and molecular assays-the study will define LBP subtypes, with a particular focus on nociceptive, neuropathic, and nociplastic mechanisms. The ultimate goal is to establish prognostic biomarkers and advance personalized strategies for LBP prevention and treatment.",[721,722,723,90,724,725,726,28,727,728,729],"Chronic Low Back Pain (CLBP)","Acute Low Back Pain","Low Back Pain","Acute Pain","Mental Disorders","Sleep Disorder","Nociplastic Pain","Neuropathic Pain","Nonspecific Low Back Pain",[731,732,733,734,735,736],"chronic low pack pain","fMRI","brain function","microbiota","nociplastic pain","treatment","2025-05-02",{"date":702,"type":39},{"date":740,"type":21},"2025-05-15",{"date":483,"type":21},{"name":743,"class":46},"Peking University Third Hospital",""]