[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"I.R.C.C.S. Fondazione Santa Lucia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":327},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,77,106,129,152,182,210,230,254,281,304],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100631394",false,"NCT07500103","Spatiotemporal Entrainment Neuromodulation Targeting Cerebello-Cerebral Circuits to Enhance Cognitive and Social Rehabilitation in Cerebellar Diseases","Spatiotemporal Entrainment as Innovative Neuromodulation Targeting Cerebello-cerebral Circuits for Enhancing Rehabilitation Outcomes of Cognitive and Social Skills in Progressive and Acquired Cerebellar Diseases","SINCRO","Inclusion Criteria for patients with cerebellar malformation include:\n\n* Documented malformations confined to the cerebellum confirmed by a 3T brain MRI scan;\n* Age ranging from 12 to 32 years old;\n* IQ \\>= 50;\n* Absence of extra-cerebellar malformations on conventional brain MRI scan.\n\nInclusion Criteria for patients with degenerative cerebellar atrophy include:\n\n* Evidence of diffuse cerebellar atrophy;\n* More than 6 months of illness;\n* IQ \\>=75;\n* Absence of any cortical lesion on conventional brain MRI scans\n\nExclusion Criteria for both groups include:\n\n* Presence of severe motor and visual impairments, as well as neurodevelopmental (i.e., autism), neurological or psychiatric disorders that could interfere with task execution and protocol compliance;\n* Presence of any contraindication for tACS.","ALL","12 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","The cerebellum is increasingly recognized for its crucial role in high-level cognitive processes, particularly in the domain of social cognition and action prediction. Disruptions in cerebellar circuits can lead to significant impairments in anticipating others' intentions and behaviors, affecting daily social interactions. This randomized, double-blind, sham-controlled trial protocol investigates the combined effects of personalized cerebellar High-Definition transcranial Alternating Current Stimulation (HD-tACS) and Immersive Virtual Reality (IVR) training on social prediction abilities. The study involves two clinical populations: adolescents and young adults with congenital cerebellar malformations (CM) and adults with acquired neurodegenerative cerebellar atrophy (CA). Participants undergo eight daily sessions of IVR training designed to enhance internal models of social events through interactive scenarios. Simultaneously, they receive either active or sham HD-tACS delivered at their Individual Gamma Frequency (IGF), determined via baseline EEG. The primary outcomes include behavioral responses to context-based social prediction tasks (action intentions, emotions, and personality traits). Secondary outcomes encompass electrophysiological measures, neuropsychological functioning, and adaptive behavior. By integrating neuromodulation with embodied virtual experiences, the project aims to facilitate cerebello-cerebral plasticity and provide a novel transdiagnostic rehabilitative approach for socio-cognitive impairments.",[26,27],"Cerebellar Degeneration","Cerebellar Malformation",[29,30,31,32],"Cerebellum","Social prediction","tACS","Virtual Reality","RECRUITING","2026-03-25",{"date":36,"type":37},"2026-03-30","ACTUAL",{"date":39,"type":37},"2025-01-15",{"date":41,"type":20},"2027-04",{"name":43,"class":44},"I.R.C.C.S. Fondazione Santa Lucia","OTHER",2,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100548382","NCT06420271","Effects of Cerebellar tACS-iTBS in Ataxia","Effects of Combined Transcranial Electrical and Magnetic Stimulation of Cerebellum on Balance Function in Ataxia Patients","EtABeta","Inclusion Criteria:\n\n1. Confirmed diagnosis of ataxia based on clinical assessment and\u002For neuroimaging findings.\n2. Stable medication regimen for at least four weeks prior to the study.\n3. Sufficient cognitive ability to understand and comply with study instructions.\n\nExclusion Criteria:\n\n1. History of seizures.\n2. Severe general impairment or concomitant diseases.\n3. Intracranial metal implants.\n4. Cardiac pacemaker.\n5. Pregnancy status.","8 Years","80 Years",{"count":56,"type":20},30,[23],"Ataxia refers to a group of neurological disorders characterized by impaired coordination and balance due to dysfunction in the cerebellum or its connections. Traditional therapeutic approaches for ataxia have shown limited efficacy, prompting researchers to explore alternative interventions. Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), and intermittent theta burst stimulation (iTBS), have emerged as potential therapeutic options. The aim of this study is to investigate the combined effect of tACS-iTBS on balance functions in ataxia disorders.",[60],"Ataxia",[62,63,64,65,66,67],"Non Invasive Brain Stimulation","Transcranial Magnetic Stimulation","Intermittent Theta Burst Stimulation","Transcranial Electrical Stimulation","Transcranial Alternating Current Stimulation","Exergaming","2026-02-12",{"date":70,"type":37},"2026-02-17",{"date":72,"type":37},"2025-05-01",{"date":74,"type":20},"2026-12-31",{"name":43,"class":44},1,{"id":78,"slug":4,"hasResults":10,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":10,"sex":16,"minAge":84,"maxAge":54,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":76},"100586153","NCT06911671","EMG Control Assistance Virtual Reality Interface Coupled With Cerebellar-iTBS for Arm Recovery After Stroke (ERICA)","Innovative Upper Limb Stroke Rehabilitation Approach Combining Myoelectric Control Assistance in Virtual Reality and Cerebellar TBS Plasticity Enhancement","ERICA","Inclusion Criteria:\n\n* First ever ischemic stroke with mild to moderate motor impairment of upper limb;\n* Left or right sub-cortical or cortical lesion of the middle cerebral artery;\n* Age\\>18, \\\u003C80 years;\n* No visuospatial, cognitive, or attention deficits;\n* Fugl-Meyer score\\\u003C56.\n\nExclusion Criteria:\n\n* History of seizures;\n* Treatment with Benzodiazepines, Baclofen;\n* Pregnancy status;\n* Intracranial metal implant;\n* Cardiac pace-maker;\n* Orthopedic upper limb limitation;\n* Upper limb pain;\n* Patients with neurological diseases beyond stroke or with neuropsychiatric disorders or with neuropsychological disorders that could potentially compromise informed consent or compliance during the study.","18 Years",{"count":86,"type":20},45,[23],"The investigators hypothesize that a myoelectric (EMG) controlled virtual reality (VR) interface allows for effective upper limb motor recovery of stroke patients. EMG control offers the possibility to alter visual feedback according to the recorded muscle activity in real-time. By manipulating the motion of a virtual hand associated with the recorded muscle patterns, assistance can be provided to stroke patients by correcting the error between the actual (dysfunctional) and a reference (functional) muscle pattern. Thus, through such an assistive EMG control algorithm, patients will be able to perform reaching movements with the virtual hand despite their motor impairment. By gradually reducing assistance, it is hypothesized that the salient error in the task space provided as visual feedback will systematically change the muscle patterns, thereby driving adaptation of the dysfunctional muscle patterns, enhancing motor recovery. Moreover, due to its relevant role in motor learning, it is expected that cerebellar stimulation will favor the underlying processes of adapting cerebello-cortical plasticity involved in motor learning. Therefore, it is hypothesized that an assistive EMG control algorithm in combination with cerebellar transcranial magnetic stimulation will further enhance upper limb recovery.",[90,91],"Stroke","Stroke, Cardiovascular",[32,93,94,63,95,96,97],"Brain Stimulation","Myoelectric Control","Cerebellar Stimulation","Motor Recovery","Tailored Assistance","2026-01-30",{"date":100,"type":37},"2026-02-03",{"date":102,"type":37},"2025-04-01",{"date":104,"type":20},"2027-10-01",{"name":43,"class":44},{"id":107,"slug":4,"hasResults":10,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":10,"sex":16,"minAge":84,"maxAge":54,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":76},"100576069","NCT06780488","Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors","Inclusion Criteria:\n\n* Subjects with a history of hemorrhagic or ischemic stroke (more than 6 months from the acute event)\n* Patients aged between 18 and 80 years\n* Absence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation \\> 24)\n* Functional Ambulation Category ≥ 3\n* Absence of associated orthopedic, visual, and\u002For neurological issues (clinically assessed) that may affect participation in the study\n\nExclusion Criteria:\n\n* Patients with stroke (less than 6 months from the acute event);\n* Patients aged under 18 and over 80;\n* Presence of associated orthopedic, visual, and\u002For neurological issues (clinically assessed) that may affect participation in the study;\n* Presence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation ≤ 24);\n* Epilepsy.",{"count":112,"type":20},38,[23],"This pilot study aims to evaluate the effect of a specfic Virtual-Reality-Based rehabilitation training in patients with stroke. A total of 38 patients with stroke (more than 6 months from the acute event), recruited from the services of the Fondazione Santa Lucia IRCCS in Rome, will be included in the present study. Participants will be randomized into two groups: a Real group and a Sham group. Both groups will undergo a rehabilitation intervention using an immersive virtual reality system. The Real group will be exposed to scenarios containing specific stimuli for the visuo-vestibular system, while the Sham group will be exposed to the same scenarios but without specific stimuli. All participants in both groups will undergo 12 treatment sessions (three times a week), each lasting 20 minutes. All treatments will be conducted by physiotherapists specialized in neurological and vestibular rehabilitation. Patients will be assessed before the start of the treatment, at the end of the intervention, and one month after its completion, in order to evaluate the effects of the experimental training on balance and gait, and on the patient's perceived quality of life. Another aim will be to assess the user's satisfaction with the new proposed protocol.",[90],[90,117,32,118,119,120],"Vestibular Rehabilitation","Balance","Gait","Quality of Life","2026-01-22",{"date":123,"type":37},"2026-01-23",{"date":125,"type":37},"2025-01-01",{"date":127,"type":20},"2027-09",{"name":43,"class":44},{"id":130,"slug":4,"hasResults":10,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":10,"sex":16,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":149,"leadSponsor":151,"locationsCount":45},"100598767","NCT07075770","Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the DMN in Mild AD Patients","Novel Personalized Non Invasive Combined Magnetic and Electrical Stimulation of the Default Mode Network in Mild AD Patients (CMES-AD)","CMES_AD","Inclusion Criteria:\n\n* Patients with a diagnosis of AD according to IWG criteria\n* 20 \\> MMSE \\\u003C 28\n* Patients with CSF specific biomarker profile or with a positive Amyloid Pet Scan consistent with the presence of amyloid pathology\n* Global Clinical Dementia Rating (CDR) ≤1\n* Previous decline in cognition for more than six months as documented in patient medical records\n* A caregiver available and living in the same household or interacting with the patient and available\n* Patients living at home or nursing home setting without continuous nursing care\n* General health status acceptable for a participation in a 6-month clinical trial\n* Stable pharmacological treatment for at least one month prior to screening\n* No regular intake of prohibited medications.\n* Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician\u002F neurologist, prior to the initiation of any study specific procedure. Signed consent of the caregiver\n\nExclusion Criteria:\n\n* Failure to undergo screening or baseline exams\n* Hospitalization or change in chronic concomitant medications one month before the screening or during the screening period\n* Clinical, laboratory, or neuroimaging results consistent with:\n\n  1. other primary degenerative dementia (Lewy body dementia, frontotemporal dementia, Huntington's disease, Creutzfeldt-Jakob disease, Down syndrome, etc.);\n  2. other neurodegenerative conditions (Parkinson's disease, amyotrophic lateral sclerosis, etc.);\n  3. orthostatic hypotension and autonomic disorders\n  4. cerebrovascular disease (major infarction, a strategic infarction or multiple lacunar infarctions, extensive white matter lesions \\> one quarter of total white matter);\n  5. other central nervous system diseases (severe traumatic brain injury, tumors, subdural hematoma, or other space-occupying processes, etc.);\n  6. seizure disorder.\n  7. Other infectious, metabolic, or systemic diseases affecting the central nervous system (syphilis, existing hypothyroidism, current vitamin B12 or folate deficiency, serum electrolytes outside normal limits, juvenile diabetes, etc.).\n* A current DSM-V diagnosis of major depression, schizophrenia, or bipolar disorder.\n* Clinically significant, advanced, or unstable disease that may interfere with primary or secondary variable assessments and may affect the assessment of the patient's clinical or mental state, or expose the patient to special risk, such as:\n\n  1. Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulties, etc.);\n  2. Opioid-containing analgesics\n  3. Suspected or known drug or alcohol abuse, i.e., more than about 60 g of alcohol (about 1 liter of beer or 500 ml of wine) per day, indicated by a high mean corpuscular volume (MCV) above the normal value at screening;\n  4. Any condition that, in the investigator's judgment, makes the patient unsuitable for inclusion","50 Years","85 Years",{"count":19,"type":20},[23],"Alzheimer's disease (AD) is increasingly recognized as a disorder marked by early synaptic dysfunction and disrupted brain network connectivity, beyond the traditional focus on amyloid pathology. Synaptic plasticity (crucial for learning and memory) is compromised in AD and represents a promising therapeutic target. In particular, alterations in the Default Mode Network (DMN), especially in regions like the precuneus, suggest that restoring connectivity and enhancing plasticity may improve cognitive outcomes. This project proposes a novel, precision-delivered non-invasive brain stimulation protocol that combines repetitive transcranial magnetic stimulation (rTMS) and transcranial alternating current stimulation (tACS) over the DMN. The intervention will be evaluated through cognitive testing, blood-based biomarkers, MRI and TMS-EEG, alongside immersive virtual environments to assess sensorimotor and cognitive function. This approach aims to test neuromodulation strategies capable of slowing neurodegeneration and supporting early detection and rehabilitation in AD.",[142],"Alzheimer Disease",[62,63,64,65,66,144],"Default Mode Network","2026-01-09",{"date":147,"type":37},"2026-01-13",{"date":125,"type":37},{"date":150,"type":20},"2027-08-31",{"name":43,"class":44},{"id":153,"slug":4,"hasResults":10,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":10,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":45},"100612753","NCT07257679","Gentle Touch for Post-Mastectomy Lymphedema","The Effects of 'Gentle Touch' in the Management of Lymphedema in Women Treated for Breast Cancer: A Preliminary Single-blind, Parallel-group Randomized Controlled Trial.","GT-BCRL","Inclusion Criteria:\n\n* Gender: Women.\n* Age: Between 30 and 75 years old\n* Surgical History: Women who have undergone surgery for breast cancer (BC). This includes being subjected to one of the following interventions: Axillary dissection with removal of all 3 lymph node levels; Axillary dissection with removal of only one lymph node level; Removal of the sentinel lymph node only.\n* Clinical Lymphedema: Clinically evaluated lymphedema symptoms, defined as a circumference difference of greater than 20mm between the two arms\n\nExclusion Criteria:\n\n* Concurrent Diseases: Concomitant diseases that may interfere with the study.","FEMALE","30 Years","75 Years",{"count":163,"type":20},36,[165],"PHASE4","This is a single-blind, parallel-group Randomized Controlled Trial (RCT) comparing the efficacy of a specialized manual technique, Gentle Touch (GT), versus a control intervention, both added to the usual rehabilitative care. The study investigates 36 women aged 30 to 75 with Breast Cancer-Related Lymphedema (BCRL). The primary objective is to evaluate the reduction of lymphedema volume in the upper limb. Secondary objectives include assessing the improvement in patients' quality of life and the potential reduction in care burden and costs. The treatment protocol involves 10 bi-weekly sessions over 5 weeks.",[168],"Lymphedema, Breast Cancer",[170,171,172,173],"Lymphedema","Breast Cancer","DLM","Gentle touch","2025-11-27",{"date":176,"type":37},"2025-12-02",{"date":178,"type":37},"2025-11-01",{"date":180,"type":20},"2027-11-01",{"name":43,"class":44},{"id":183,"slug":4,"hasResults":10,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":189,"sex":16,"minAge":84,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":76},"100573060","NCT06741358","Using Glialia for Treating Persistent Perceptual Postural Dizziness","Use of the Glialia Supplement in the Treatment of Persistent Perceptual Postural Imbalance: A Triple-Blind, Randomized, Placebo-Controlled Pilot Clinical Trial","GLI-PPPD","Inclusion criteria for all groups:\n\n-Age between 18 and 65 years.\n\nInclusion criteria for the PPPD-glialia group:\n\n* Diagnosis of PPPD;\n* Recovery from COVID-19 infection or absence of previous infection.\n\nInclusion criteria for the PPPD-placebo group:\n\n* Diagnosis of PPPD;\n* Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group).\n\nExclusion criteria for all PPPD-group:\n\n* Presence of concurrent neurological and otological disorders other than PPPD;\n* Pregnant women.\n\nInclusion criteria for the control group:\n\n-Previous COVID-19 infection (matched for timing to the PPPD-glialia group).\n\nExclusion criteria for the control group:\n\n* Presence of neurological and otological disorders;\n* Pregnant women.",true,"65 Years",{"count":56,"type":20},[165],"This pilot study will involve 30 participants recruited from the Santa Lucia Foundation IRCCS, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD), and might or might not have previously contracted Sars Cov2 infection. They who will be randomly assigned to receive either the Glialia supplement or placebo. Additionally, 10 control participants who have recovered from COVID-19 will receive Glialia to help assess the influence of previous COVID-19 infection on neuroinflammation levels. The study aims to compare baseline neuroinflammation levels between PPPD patients and controls, measure changes in neuroinflammation in all groups after treatment and to determine if the reduction in neuroinflammation is more significant in the Glialia group compared to the placebo group. The trial will be conducted in a triple-blind manner, ensuring that neither participants nor researchers know the treatment assignments. Each participant will receive sachets to be taken daily for 60 days, with the study providing both the Glialia supplement and placebo at no cost.",[195],"Persistent Postural Perceptual Dizziness",[197,198,199,200,201,118],"Persistent Perceptual Postural Dizziness","Functional disorder","Neuroinflammation","Human Palmitoylethanolamide (umPEA)","Neurofilaments","2025-11-17",{"date":204,"type":37},"2025-11-20",{"date":206,"type":37},"2024-12-21",{"date":208,"type":20},"2026-10-10",{"name":43,"class":44},{"id":211,"slug":4,"hasResults":10,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":189,"sex":16,"minAge":215,"maxAge":4,"enrollmentInfo":216,"targetDuration":218,"studyType":219,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":76},"100580787","NCT06841848","Fundus Camera Module for Early Detection of Alzheimer's Disease","Inclusion Criteria:\n\n* 55 years or older\n* Diagnosis:\n\n  1. For AD group: Clinically diagnosed with Alzheimer's disease (mild to moderate stage) based on Mini-Mental State Examination (MMSE) score between 10-26 and confirmed by PET imaging or CSF.\n  2. For Control group: No diagnosis of Alzheimer's disease or other neurodegenerative disorders.\n* Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician\u002F neurologist, prior to the initiation of any study specific procedure\n\nExclusion Criteria:\n\n* Severe cognitive impairment (MMSE \\\u003C10) preventing cooperation during the imaging process.\n* Inability to remain still during the fundus imaging procedure.","55 Years",{"count":217,"type":20},80,"1 Day","OBSERVATIONAL","Alzheimer's Disease (AD) affects tens of millions of people just in Europe. It is typically detected in its late stage when irreversible damage has already occurred, and current treatments are mostly conservative or palliative. Here we developed a device performing high-resolution multispectral imaging of the eye fundus to detect AD in its early stage. After clinical testing, the proposed device has a high potential to become a method for routine population screening, as it is non-invasive and affordable. The possibility of AD detection in an early stage is crucial for developing a new pharmaceutical treatment that would dramatically improve the lives of millions and save the expenses connected to lifelong healthcare assistance to people with AD in later stages.",[142],"2025-02-21",{"date":224,"type":37},"2025-02-24",{"date":226,"type":37},"2023-05-01",{"date":228,"type":20},"2026-03",{"name":43,"class":44},{"id":231,"slug":4,"hasResults":10,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":10,"sex":16,"minAge":136,"maxAge":137,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":241,"conditions":242,"keywords":243,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":76},"100570044","NCT06702124","A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease","Effects of Dopaminergic Therapy in Patients with Alzheimer's Disease: a 24 Weeks Prospective, Randomized, Double-blind, Placebo-controlled, Parallel Group, International, Multi-center Phase III Study Evaluating Efficacy and Safety of Rotigotine 4 Mg\u002F24 Hrs in Combination with Rivastigmine 9.5 Mg\u002F24 Hrs in Mild to Moderate Alzheimer's Disease Patients.","DOPAD-3","Inclusion Criteria:\n\n1. Men and women (non-childbearing potential, as defined in Appendix 2) with a diagnosis of AD according to IWG criteria\n2. Age 50-85 years\n3. MRI or computerized tomography (CT) assessment, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions (see exclusion criteria, number 3)\n4. Patients who show CSF biomarker data supporting the diagnosis of AD (for Czech Republic only: lumbar punctures can be performed for screening purposes), or patients with a positive Amyloid Pet Scan will qualify for the study\n5. Stable on a treatment with rivastigmine transdermal patch for at least 3 months, of which at least the last month was at 9.5mg\u002Fday, or for one month, if the patient had received donepezil before rivastigmine\n6. Mild to moderate stage of AD according to MMSE ≥18 and ≤26\n7. Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild)\n8. Evidence of frontal lobe dysfunctions as assessed by FAB ≤14\n9. Absence of major depressive disease according to GDS of \\\u003C 5\n10. Formal education for five or more years\n11. Previous decline in cognition for more than six months as documented in patient medical records\n12. A caregiver available and living in the same household or interacting with the patient and available if necessary to assure administration of drug\n13. Patients living at home or nursing home setting without continuous nursing care\n14. General health status acceptable for a participation in a 6-month clinical trial\n15. Stable pharmacological treatment of any other chronic condition for at least one month prior to screening\n16. No regular intake of prohibited medications\n17. Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician\u002F neurologist, prior to the initiation of any study specific procedure. Signed consent of the caregiver\n\nExclusion Criteria:\n\n1. Failure to perform screening or baseline examinations\n2. Hospitalization or change of chronic concomitant medication one month prior to screening or during screening period\n3. Clinical, laboratory or neuro-imaging findings consistent with:\n\n   * other primary degenerative dementia (dementia with Lewy bodies, fronto- temporal dementia, Huntington's disease, Creutzfeldt-Jakob Disease, Down's syndrome, etc.);\n   * other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.);\n   * orthostatic hypotension and autonomic disorders\n   * cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions \\> one quarter of the total white matter);\n   * other central nervous system diseases (severe head trauma, tumors, subdural hematoma or other space occupying processes, etc.);\n   * seizure disorder;\n   * other infectious, metabolic, or systemic diseases affecting the central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.).\n4. A current DSM-V diagnosis of active major depression, schizophrenia, or bipolar disorder\n5. Any suicidal ideation or suicidal behavior in the C-SSRS (C-SSRS score \\> 0)\n6. Clinically significant, advanced, or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as:\n\n   * history of any kind of psychosis\n   * chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, Gamma GT, alkaline phosphatase \\> 2.5 ULN);\n   * respiratory insufficiency;\n   * renal insufficiency (serum creatinine \\>2 mg\u002Fdl) or creatinine clearance ≤ 30 mL\u002Fmin according to Cockcroft-Gault formula). In case of creatinine clearance ≤30 mL\u002Fmin, an alternative verification of the renal function must be completed using Cystatin C analysis. In case of normal level of Cystatin C, the patient can be included;\n   * heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within six months before screening);\n   * bradycardia (heart beat \\\u003C50\u002Fmin.) or tachycardia (heart beat \\>95\u002Fmin);\n   * hypertension (\\>140\u002F90 mm\u002FHg) or hypotension (\\\u003C90\u002F60 mm\u002FHg) requiring treatment with more than three drugs;\n   * AV block (type II \u002F Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males \\>450 and females \\>470 msec);\n   * uncontrolled diabetes defined by HbA1c \\>8.5;\n   * malignancies within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer;\n   * metastases;\n   * disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.);\n   * women who are fertile and of childbearing potential;\n   * chronic daily drug intake of ≥ 14 days or expected for ≥ 14 days:\n   * benzodiazepines, neuroleptics or major sedatives,\n   * antiepileptics,\n   * centrally active anti-hypertensive drugs (clonidine, l-methyl DOPA, guanidine, guanfacine, etc.),\n   * opioid containing analgesics,\n   * nootropic drugs (except Ginkgo Biloba);\n   * suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 500 ml of wine) per day, indicated by elevated mean corpuscular volume (MCV) above normal value at screening; (Please advise all subjects that because of possible additive effects, patients should not be taking alcohol in combination with rotigotine).\n   * suspected or known allergy to any components of the study treatments;\n   * hypersensitivity to the active substance rotigotine or to any of the excipients contained in the patches (according to SmPC).\n   * enrollment in another investigational study or intake of investigational drug within the previous three months or five times the half-life of the IMP\u002Fmetabolites (whichever is longer)\n   * any condition, which, in the opinion of the investigator, makes the patient unsuitable for inclusion;\n   * if the patient is in any way dependent on the sponsor or the principal investigator or if the patient is accommodated in an establishment on judicial or administrative order.",{"count":238,"type":20},348,[240],"PHASE3","This is a 24-week prospective, randomized, double-blind, placebo-controlled, multi-center phase III study evaluating efficacy and safety of rotigotine 4mg\u002F24 hrs in combination with rivastigmine 9.5 mg\u002F24 hrs in mild to moderate AD patients. The total study duration per patient from baseline to the end will be 24 weeks. The study has a placebo-controlled design to eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources.",[142],[244,245],"Dopamine","Rotigotine","2025-01-17",{"date":248,"type":37},"2025-01-22",{"date":250,"type":37},"2023-12-01",{"date":252,"type":20},"2026-04",{"name":43,"class":44},{"id":255,"slug":4,"hasResults":10,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":189,"sex":16,"minAge":215,"maxAge":54,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":76},"100549069","NCT06429215","REducing the Risk of COgnitive DEcline ad Dementia in Patients With Subjective Cognitive Decline Through an Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: the SCD-ReCODED Study","Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: a Randomized Controlled Trial","SCD-ReCODED","Inclusion Criteria:\n\n* Self-perceived decline in cognition compared to five years ago\n* Lack of objective cognitive impairment.\n\nExclusion Criteria:\n\n* Clinically significant depression and anxiety;\n* Psychiatric disorders;\n* Unstable medical conditions.\n* Severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution\n* Dizziness or epilepsy history;",{"count":262,"type":20},75,[23],"Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. To date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. In this framework, the aim of this project is to evaluate the efficacy of an Immersive Virtual Reality (IVR) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., SCD). For this purpose, a randomized, double-blinded controlled trial (RCT) will be conducted on seventy-five eligible individuals with SCD, who will be randomly assigned to one of three conditions: (a) multi-component intervention (MC-I), including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention (CO-I), including the SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention (AC-I) for both cognitive training and education program. Intervention will be provided in 20 at-home sessions (4 sessions\u002Fweek, each lasting about 30 minutes) over a period of 5 weeks. Outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.",[266],"Subjective Cognitive Decline",[268,269,270,271,272],"Subjective cognitive decline","Multi-component training","Non-pharmacological intervention","Virtual reality","Telemedicine","2024-09-30",{"date":275,"type":37},"2024-10-01",{"date":277,"type":37},"2024-07-01",{"date":279,"type":20},"2025-12",{"name":43,"class":44},{"id":282,"slug":4,"hasResults":10,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":10,"sex":16,"minAge":160,"maxAge":54,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":76},"100545291","NCT06379997","Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies","Efficacy of Oral Hyaluronic Acid and Collagen Supplementation Compared With Hyaluronic Acid Infiltration Treatment in Rotator Cuff Tendinopathies: A Prospective Study","Inclusion Criteria:\n\n* Persistent shoulder pain lasting for at least 2 months unresponsive to conservative treatment (nonsteroidal anti-inflammatory drugs \\[NSAIDs\\] and rehabilitation)\n* Ultrasound or MRI evidence of a rotator cuff lesion without complete tendon rupture\n* Limited active range of motion (ROM) in the shoulder\n\nExclusion Criteria:\n\n* Traumatic shoulder injury as the cause of pain\n* History of shoulder dislocation, fracture, or previous shoulder surgery\n* Presence of signs indicating ligamentous instability\n* Severe shoulder arthrosis, adhesive capsulitis, or calcific tendinitis\n* Previous infiltrative treatment with corticosteroids, hyaluronic acid, or collagen within the past 6 months\n* Diagnosis of rheumatic or neoplastic diseases\n* Ongoing therapy with anticoagulants\n* Cervical radiculopathy\n* Pregnancy\n* History of heart, kidney, or liver failure\n* Cognitive impairment",{"count":288,"type":20},50,[23],"The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections.\n\nThe project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2).\n\nThe hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality.\n\nFunctional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used:\n\nNumeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement.\n\nShoulder Disability Questionnaire (SDQ) for functionality.\n\nAssessments will be conducted at the following time points:\n\nT0) Before the administration of corticosteroid intra-articular injection (baseline).\n\nT1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0).\n\nT2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1).\n\nT3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0).",[292,293,294,295],"Tendinitis of Shoulder","Hyaluronic Acid","Dietary Supplements","Shoulder Pain","2024-08-27",{"date":298,"type":37},"2024-08-29",{"date":300,"type":37},"2024-08-10",{"date":302,"type":20},"2025-12-31",{"name":43,"class":44},{"id":305,"slug":4,"hasResults":10,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":10,"sex":16,"minAge":84,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":319,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":326,"locationsCount":4},"100503158","NCT05831618","New Rehabilitation Protocol for Patients With PPPD","New Rehabilitation Protocol for Patients With Persistent Postural Perceptual Dizziness","Inclusion Criteria:\n\n* Diagnostic criteria established for PPPD by the Barany Society (Staab et al., 2017) will be adopted\n\nExclusion Criteria:\n\n* Patients with neurological, otological or psychiatric disorders other than PPPD will be excluded.","60 Years",{"count":312,"type":20},40,[23],"The investigators will test a new rehabilitation protocol on patients with persistent postural perceptual dizziness (PPPD). The investigators hypothesize that patients with PPPD, in the absence of vestibular deficits, do not benefit from standard vestibular rehabilitation but instead need a rehabilitation that acts on visual and postural stability, through training of saccadic movements in dynamic contexts of cognitive-motor dual-task and rehabilitation of postural stability.",[316,118,317,318],"Rehabilitation","Vestibular Disorder","Dizziness","NOT_YET_RECRUITING","2023-07-12",{"date":322,"type":37},"2023-07-13",{"date":324,"type":20},"2023-07-30",{"date":74,"type":20},{"name":43,"class":44},""]