Restless Leg Syndrome Rls

9

Review clinical trials related to Restless Leg Syndrome Rls. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

The Effect of Spinal Cord Stimulators on Restless Leg Syndrome

This study aims to evaluate neurophysiological responses and symptom changes in individuals with Restless Legs Syndrome (RLS) and/or chronic pain. Participants will undergo standard clinical assessments including EEG, EMG, h-reflex, SSEP, ERP, and TMS under varying SCS conditions.The study involves 4 arms. Arm 1 are individuals diagnosed with RLS and Healthy Controls. Arm 2 are individuals diagnosed with RLS and have an existing SCS. Arm 3 are individuals diagnosed with RLS and scheduled to receive a SCS. Arm 4 are individuals with chronic pain and have a SCS, but no diagnosis of RLS.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Jun 26, 2026Locations: 1
Eligibility criteria

Has Restless Leg Syndrome [+4]

Any mental or physical limitation that would prevent completing any of the studi... [+6]

Status: Not yet recruiting

Study on the Efficacy of Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS

A Double-Blind Randomized Controlled Crossover Study to compare the short-efficacy of Burst-SCS with Sham Stimulation, in patients with severe to very severe RLS refractory or intolerant to standard available treatments and/or patients in augmentation, with a two-period-alternating treatment design.

Participants needed: 15
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Clinica ARS MedicaUpdated: May 6, 2026Locations: 2
Eligibility criteria

Male and female (all sexes) aged 18 years or older, inclusive; [+8]

Known hypersensitivity or allergy to the materials of the device; [+11]

Status: Recruiting

Using Cannabis to Treat Restless Legs Syndrome

Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.

Participants needed: 30
Trial details
Age: 25+Biological sex: AllType: InterventionalSponsor: Sunnybrook Health Sciences CentreUpdated: Apr 28, 2026Locations: 2
Eligibility criteria

≥25 years of age [+3]

sleep disordered breathing, or sleep disordered breathing that is not adequately... [+7]

Status: Recruiting

Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety

The goal of this \[study type: clinical trial\] is to \[primary purpose: evaluate the efficacy and safety of a novel calcium channel modulator in treating Restless Legs Syndrome (RLS) and its variant subtypes\] in \[describe participant population/primary condition: adult patients aged 18-75 years with confirmed RLS or its variant subtypes, who meet the study's eligibility criteria\]. The main question\[s\] it aims to answer \[is/are\]: * Does the novel calcium channel modulator improve RLS-related symptoms (assessed by the International Restless Legs Syndrome Study Group Rating Scale, IRLS) after the treatment period? * What is the safety profile (incidence of adverse events) of this calcium channel modulator in RLS patients? Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given\]: * Receive oral administration of the novel calcium channel modulator (40mg twice daily) for 12 consecutive weeks * Complete scheduled follow-up visits for symptom assessments, safety monitoring, and questionnaire completion

Participants needed: 20
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Beijing Friendship HospitalUpdated: Mar 6, 2026Locations: 1
Eligibility criteria

1. Aged 18-75 years, regardless of gender. [+3]

1. Secondary RLS (e.g., iron deficiency anemia with serum ferritin <30μg/L, rena... [+7]

Status: Not yet recruiting

Effect of Autogenic Training on Hemodialysis Patients

goal of this interventional study to investigate the effect of autogenic training on sleep disturbance , restless leg syndrome and fatigue on hemodialysis patient Is there any significant effect of autogenic training on restless leg syndrome, sleep disturbance and fatigue in patients with hemodialysis? The intervention will include structured autogenic training sessions, and outcomes such as sleep quality and RLS severity and fatigue will be evaluated after 8 weeks of autogenic training on hemodialysis patients .

Participants needed: 54
Trial details
Age: 45-55Biological sex: AllType: InterventionalSponsor: Cairo UniversityUpdated: Dec 22, 2025Locations: 1
Eligibility criteria

Age between 45 and 55 years. [+3]

Status: Not yet recruiting

Combined Effects of Near-Infrared Light and Vibration on Diabetic Patients With Restless Leg Syndrome

This Randomized Clinical Trial, titled "Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptom Severity in Diabetic Patients with Restless Leg Syndrome," aims to evaluate a non-pharmacological treatment for Restless Leg Syndrome (RLS) in diabetic patients. RLS is a neurological disorder causing an irresistible urge to move the legs, and its co-occurrence with diabetes significantly worsens symptoms, pain, and sleep quality. While both Near-Infrared (NIR) light therapy and vibration therapy have individually shown benefits, this study will investigate the potential synergistic effects of combining them. 42 diabetic patients with RLS (aged 50-65) will be randomly assigned to one of three groups for four weeks (3 sessions/week): Group A (Vibration + Conventional Stretching), Group B (NIR Light + Conventional Stretching), and Group C (Combined Vibration and NIR Light + Conventional Stretching). Outcomes will be measured at baseline, 4 weeks, and 6 weeks using the International Restless Leg Syndrome Rating Scale (IRLS), the Pittsburgh Sleep Quality Index (PSQI), and the Numeric Pain Rating Scale (NPRS). This research explores the synergistic effects of near-infrared light and vibration therapy on Restless Leg Syndrome (RLS) symptoms in diabetic patients, aiming to alleviate symptoms, improve sleep quality, and enhance overall well-being.

Participants needed: 42
Trial details
Age: 50-65Biological sex: AllType: InterventionalSponsor: Lahore University of Biological and Applied SciencesUpdated: Dec 29, 2025
Eligibility criteria

Not listed

Status: Recruiting

Peroneal Electrical Nerve Stimulation in Pregnancy for Restless Legs Syndrome

The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. This pilot study will also collect preliminary information on symptom relief, sleep quality, and maternal-fetal safety associated with device use. The main questions the study aims to answer are: Is TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population? Participants will: Use a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks. Complete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II). Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks. Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment. This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.

Participants needed: 15
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Rhode Island HospitalUpdated: Nov 12, 2025Locations: 2
Eligibility criteria

Age ≥18 years [+5]

History of preterm labor [+15]

Status: Recruiting

Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment

The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS). Similar studies in Parkinson's disease have shown changes in alpha-synuclein expression, which might offer insights into the dopaminergic gene regulation seen in RLS. The dopamine agonist drugs to be included in this study are: Pramipexole (Mirapex), Ropinirole (Requip), Rotigotine (Neupro), Apomorphine (Apokyn), Bromocriptine (Parlodel). Specifically, the study will collect nasal swabs of participants partitioned into two groups, those who have not used a dopamine agonist or been on a dopamine agonist for less than 1 month compared to those who have been on the medication for 6 or more months. This research could provide insight into changes in dopaminergic gene expression associated with Augmentation Syndrome (AS) which occurs after long term dopamine agonist treatment in RLS patients.

Participants needed: 50
Trial details
Age: 18-60Biological sex: AllType: ObservationalSponsor: HBC Immunology IncUpdated: Sep 11, 2025Locations: 1
Eligibility criteria

Able to provide Informed Consent [+2]

Status: Recruiting

Effects of PNF Stretching vs Conventional Physical Therapy on the Symptoms of Restless Leg Syndrome in Elderly Population.

Restless leg Syndrome (RLS) is a common condition in the elderly population,characterized byan uncontrollable urge to move the leg,often occuring in the evening or at night,which can significantly disturb sleep and daily activities(ADL). Although various type of stretchings found to be effective on the symptoms of RLS,no study has specifically compared the effects of Proprioceptive Neuromuscular Facilitation stretching technique versus conventional physical therapy on the symptoms of RLS and related sleep disturbances.This study aims to fill this gap by evaluating the effectiveness of PNF stretching compared to conventional physical therapy,on the symptoms of RLS in elderly population.

Participants needed: 24
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: Foundation University IslamabadUpdated: Dec 24, 2024Locations: 1
Eligibility criteria

Age 60 and above. [+2]

A history or underlying disease that would contribute to the symptoms of RLS.