[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"restless-legs-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:restless-legs-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,77,101,125,152,174,198,224,252,283],{"id":9,"slug":10,"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100623485","tonic-motor-activation-tomac-therapy-in-patients-with-restless-legs-syndrome-and-dopaminergic-augmentation-100623485",false,"NCT07397247","Tonic Motor Activation (TOMAC) Therapy in Patients With Restless Legs Syndrome and Dopaminergic Augmentation","Evaluating Response to Tonic Motor Activation (TOMAC) Therapy for Patients With Restless Legs Syndrome and Dopaminergic Augmentation","CT-10","Inclusion Criteria:\n\n* Adult 18 years of age or older when written informed consent is obtained.\n* Diagnosis of restless legs syndrome confirmed by IRLSSG criteria.\n* Moderate-severe RLS, IRLS ≥15 points at study entry\n* Dopaminergic augmentation based on clinician assessment and ASRS (augmentation severity rating scale) ≥5 points at study entry\n* Subject agrees to not change the dose or schedule of antidepressants and sleep medications.\n* Currently taking stable dose and schedule of dopamine agonist over the 4 weeks prior to enrollment, with average daily dose \\>= 25mg Levodopa Equivalent Daily Dose (LEDD, https:\u002F\u002Fpdmedcalc.co.uk\u002Fcalculator).\n* Patient reports ≥3 nights per week in the 30d prior to study entry: waking during the sleep period with RLS symptoms that interfered with sleep re-initiation\n* RLS sensory symptoms in lower legs and\u002For feet are equally or more distressing than RLS sensory symptoms in all other anatomical locations.\n* The subject possesses the necessary equipment, internet\u002Fphone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.\n* The subject has signed a valid, IRB-approved informed consent form and can understand the requirements of the study and instructions for device usage.\n\nExclusion Criteria:\n\n* Baseline ferritin \\\u003C75 ng\u002FmL or patient is unwilling to consider iron supplementation.\n* IV iron supplementation in the 6 months prior to study entry.\n* Change to dose of RLS prescription medication(s) in the 4 weeks prior to study entry.\n* Medications that are known to exacerbate RLS symptoms, including: Sedative antihistamines, Tri\u002Ftetracyclics, MAOIs, SSRIs and SNRIs, Tramadol, Neuroleptics, Antiemetics, or the anticonvulsants Phenytoin or Methsuximid\n* Change in medication that is known to affect RLS symptoms in the 4 weeks prior to study entry (e.g. sleep medication, antihistamines, antidepressants).\n* Primary sleep disorder other than RLS that significantly interferes with sleep at the time of screening visit (e.g. obstructive sleep apnea with adherent CPAP usage would not be an exclusion but typical sleep onset latency of \\>60min on nights without RLS symptoms would be an exclusion).\n* Irregular sleep schedule: subject reports that bedtime is typically outside of 21:00 - 03:00 or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.\n* Subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.\n* During the initial investigational device titration process, sensation threshold \\>= 30mA or distraction threshold \\\u003C 15mA, or the device does not properly fit the subject.\n* One or more of the following confounding comorbidities: Stage 4-5 chronic kidney disease or renal failure , Iron-deficient anemia, Severe cardiac disease (NYHA class IV), Movements disorder other than RLS (Parkinson's disease, Huntington's disease, dyskinesia, dystonia), Multiple Sclerosis , Moderate-severe cognitive disorder (MoCA\\\u003C26) or mental illness, Moderate-severe edema affecting the lower legs\n* One or more of the following contraindications to the investigational device: Diagnosis of epilepsy or other seizure disorder, Metal implant in upper fibula, Known allergy to device materials (or severe previous reaction to medical adhesives or bandages), Open sores, or injury at or near the location of therapy device application.\n* Known to be pregnant or trying to become pregnant.\n* Medical condition not listed above that may affect validity of the study or put the subject at risk as determined by the investigator.\n* Subject is using another investigational device or drug during the study.\n* Subject does not understand the study requirements or device instructions, does not have the ability to complete the study assessments, or is unable or unwilling to comply with study requirements.","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study evaluates Tonic Motor Activation (TOMAC) therapy in adults with restless legs syndrome and dopaminergic augmentation. Participants use a noninvasive peroneal nerve stimulation device over a defined treatment period to assess symptom response and medication use.",[27],"Restless Legs Syndrome",[29,30,31,32,33],"Tonic Motor Activation","TOMAC","Dopaminergic augmentation","Peripheral nerve stimulation","Sleep disorder","NOT_YET_RECRUITING","2026-02-02",{"date":37,"type":38},"2026-02-09","ACTUAL",{"date":40,"type":21},"2026-04",{"date":42,"type":21},"2027-01",{"name":44,"class":45},"Noctrix Health, Inc.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":74,"locationsCount":46},"100492731","ecological-momentary-assessment-in-patients-with-restless-legs-syndrome-100492731","NCT05695963","Ecological Momentary Assessment in Patients With Restless Legs Syndrome","Feasibility, Validity and Clinical Utility of Ecological Momentary Assessment in Patients With Restless Legs Syndrome: a Prospective Study. DAILY-REST","DAILY-REST","Inclusion Criteria:\n\n* Patient over 18 years old and less than 70\n* Any patient with a diagnosis of idiopathic RLS based on medical history and the presence of the 5 RLS diagnostic criteria\n* Normal clinical examination\n* Person affiliated or benefiting from a social security scheme\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research).\n\nExclusion Criteria:\n\n* Any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia, obsessive compulsive disorder, attention-deficit\u002Fhyperactivity disorder ...) or mood disorder\n* History or presence of chronic pain other than that associated with RLS, history of epilepsy or serious head injury, history of peripheral neuropathy, diabetes\n* Clinically significant sleep apnea, narcolepsy, or any secondary causes of RLS (e.g. chronic renal failure\u002Fhemodialysis, pregnancy)\n* Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or interfere with study assessments or compromise the study participation\n* Pregnant or breastfeeding woman\n* Persons referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).","70 Years",{"count":57,"type":21},62,[24],"The Restless Legs Syndrome (RLS) is a sensorimotor disorder better characterized by an urge to move the legs at rest. Although treatments are available, many patients experience periods of symptoms relief and exacerbation. Whether this is due to the natural history of the disease or to health-related behaviors of daily life is presently unknown. The primary objective is to examine the feasibility of mobile technology to assess RLS symptoms severity fluctuations in daily life by collecting real-time data. The secondary objectives will be to examine the validity of this technic in the context of RLS and to use these real-time data to identify daily life risk factors for symptom onset or aggravation.",[27],[27,62,63,64,65,66],"Risk Factor","Ecological Momentary Assessment","Mobile Technology","Sleep","Actigraphy","RECRUITING","2025-11-19",{"date":70,"type":38},"2025-11-20",{"date":72,"type":38},"2024-01-15",{"date":42,"type":21},{"name":75,"class":76},"University Hospital, Bordeaux","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100280383","analysis-of-sympathetic-activity-in-willis-ekbom-disease-100280383","NCT02929732","Analysis of Sympathetic Activity in Willis-Ekbom Disease","MIBG-RLS","Inclusion Criteria:\n\n* Non-specific inclusion criteria (CASE + CONTROL)\n\n  * 18 years-old or more, and less than 75 years-old\n  * French-speaking\n  * able to understand the study\n  * signed written informed consent\n  * affiliated to social security\n* CASE-specific inclusion criteria\n\n  * 5 \" International RLS Study Group (IRLSSG) 2012 \" positive criteria\n  * RLS severity scale (IRLS) score ≥ 15\n  * ferritin \\> 50 ng\u002Fml\n  * periodic limb movements index \\> 10\u002Fhour\n  * idiopathic (or primary) Willis-Ekbom disease not treated with dopaminergic agonists or pregabalin or gabapentin in the last 8 days, at least 3 years of disease duration with symptoms recurring at least 3 times a week\n\nExclusion Criteria:\n\n* Non-specific exclusion criteria (CASE + CONTROL)\n\n  * vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship), pregnant or breastfeeding woman\n  * exclusion period after other research protocol\n  * malignant neoplastic disease treated in the last 12 months\n  * medical history of cardiovascular disease (ischemic heart disease, heart failure, stroke, hypertension, sleep apnea syndrome)\n  * antidepressant, neuroleptic, sympathomimetic, sympatholytic, vasculotropic, dopamine agonists, opiate treatments\n* CASE-specific exclusion criteria\n\n  \\- restless legs syndrome secondary to renal failure, hemochromatosis, neurologic disorders, iatrogenesis\n* CONTROL-specific exclusion criteria - Willis-Ekbom Disease",true,"74 Years",{"count":87,"type":21},40,[24],"Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common neurological sensorimotor disorder that typically impairs sleep and quality of life, likely consequent to a central dopaminergic dysfunction associated to brain iron deficiency. Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are often associated with micro-arousals that contribute to sleep fragmentation and repeated increases of blood pressure and heart rate throughout the night, thus representing an increased risk for hypertension and cardiovascular diseases (CVD).\n\nWillis-Ekbom disease affects people with higher cardiovascular risk factors, such as advanced age, obesity, diabetes mellitus and hypercholesterolemia. However, previous observational, cross-sectional or longitudinal population-based studies on the association between RLS and CVD and hypertension showed controversial results.\n\nWhile the pathophysiology of RLS is yet to be elucidated and is likely multifactorial, one theory involves a reduction in dopaminergic outflow to the preganglionic sympathetic neurons in the dorsal horn of the spinal cord. Dopamine inhibits preganglionic sympathetic neurons, therefore a reduction in dopamine may in turn increase sympathetic outflow.\n\nBased on this notion, the investigators hypothesize an increase of sympathetic autonomic activity in Willis-Ekbom disease responsible for the recurrent increase in blood pressure and heart rate during sleep, which may play a role in increasing the risk of cardiovascular diseases.\n\nThe aim of this study is to analyze the autonomic nervous activity in patients with WED compared to healthy volunteers controls. The investigators will measure primarily the cardiac sympathetic activity by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy and secondarily the sympathetic nerve activity by the plasmatic pro inflammatory biomarkers and urinary catecholamine levels and the circadian variation of blood pressure and heart rate as assessed by the 24-hour ambulatory blood pressure monitoring.",[91,27],"Willis-Ekbom Disease","2025-09-26",{"date":94,"type":38},"2025-10-02",{"date":96,"type":38},"2017-03-21",{"date":98,"type":21},"2027-10-05",{"name":100,"class":76},"University Hospital, Montpellier",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":84,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":122,"leadSponsor":124,"locationsCount":46},"100593088","functional-connectivity-of-the-interoceptive-network-in-rls-100593088","NCT07001891","Functional Connectivity of the Interoceptive Network in RLS","Functional Connectivity of the Interoceptive Network in Restless Legs Syndrome (RLS) : an Anatomical-clinical Prospective Study Based on Daily-life Assessment","IntoRLS","Inclusion Criteria:\n\n* Person aged from 18 to 70 years\n* Only for the patients : ny patient with a diagnosis of idiopathic RLS based on medical history and the presence of the 5 RLS diagnostic criteria\n* Normal clinical examination\n* Person affiliated or benefiting from a social security scheme\n* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research).\n\nExclusion Criteria:\n\n* Any significant psychiatric illness or mood disorder\n* History or presence of chronic pain other than that associated with RLS, history of epilepsy or serious head injury, history of peripheral neuropathy, diabetes\n* Clinically significant sleep apnea, narcolepsy, or any secondary causes of RLS (e.g. chronic renal failure\u002Fhemodialysis, pregnancy)\n* Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or interfere with study assessments or compromise the study participation\n* Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia or refusing MRI)\n* Pregnant or breastfeeding woman\n* Persons referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).",{"count":110,"type":21},30,[24],"Restless Legs Syndrome (RLS) is a sensorimotor disorder primarily characterized by an irresistible urge to move the legs while at rest. A key hypothesis suggests that RLS symptoms are linked to abnormal brain function in processing internally generated stimuli, particularly interoception. This distorted perception of the internal bodily state leads to maladaptive behaviors, which may manifest across a wide range of medical and psychiatric disorders. Here, the investigators hypothesize that dysfunction in the insular cortex (IC) may result in a failure of behavioral adaptation, primarily expressed as an urge to move the legs and hyperarousal, even when the body and mind need rest. This project aims to assess the relationship between interoceptive abilities and diurnal fluctuations in IC functional connectivity (FC) in patients with RLS compared to healthy controls. The investigators will also examine correlations between the FC of the interoceptive network, measured in the morning and evening on the same day, using multilayer network analysis, daily fluctuations in RLS symptom severity, and objective measurements of the sleep\u002Fwake cycle, gathered through a two-week ambulatory assessment using mobile technologies such as Ecological Momentary Assessment (EMA) and actigraphy, along with scores from self-reported questionnaires. The findings may provide strong evidence to support or refute the hypothesis of interoceptive dysfunction in RLS patients.",[27],[27,115,116,117],"Interoception","Insular Cortex","Functional Connectivity","2025-09-16",{"date":120,"type":38},"2025-09-17",{"date":118,"type":38},{"date":123,"type":21},"2026-10",{"name":75,"class":76},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":84,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100568711","prevalence-and-characteristics-of-restless-leg-syndrome-in-thai-patients-with-parkinsons-disease-100568711","NCT06684782","Prevalence and Characteristics of Restless Leg Syndrome in Thai Patients With Parkinson's Disease","Inclusion Criteria:\n\n* Patients with Parkinson's disease aged from 18 to 80 years who met the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Diagnostic criteria.\n\nExclusion Criteria:\n\n* Patients with atypical or secondary parkinsonism.\n* Patients with Mini-mental status exam (MMSE) less than 24 of 30.\n* Patients with secondary causes of restless leg syndrome including end-stage renal disease, iron deficiency anemia and pregnancy.","80 Years",{"count":133,"type":21},310,"OBSERVATIONAL","Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by pathologic intraneuronal alpha-synuclein-positive Lewy bodies and neuronal cell loss. The cardinal clinical symptoms and signs of PD are bradykinesia, rigidity, tremor, postural instability, and freezing attacks. The prevalence of PD increases with age, affecting 1-2% of the population over the age of 65 years, and 3% of those over 85 years.\n\nRestless legs syndrome (RLS) represents disturbing symptoms in lower limbs that lead to the urge to move, occurring in rest periods. Movements can partially or completely relieve these abnormal feelings. In 2014, the International RLS Study Group (IRLSSG) established five mandatory criteria for the diagnosis of RLS. Several studies supported that RLS and PD may share pathophysiological mechanisms.",[27],[138,139,140,141],"restless leg syndrome","parkinson's disease","prevalence","Thai population","2025-05-12",{"date":144,"type":38},"2025-05-15",{"date":146,"type":38},"2024-12-01",{"date":148,"type":21},"2026-11-30",{"name":150,"class":76},"Siriraj Hospital",2,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":46},"100578099","restless-leg-syndrome-is-there-a-response-to-buddhist-walking-meditation-in-hemodialysis-100578099","NCT06806891","Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis","Inclusion Criteria:\n\n* hemodialysis patient (40)\n* complain of restless leg syndrome\n* non obese patients\n\nExclusion Criteria:\n\n* cardiac patients\n* chest diseases\n* mental diseases\n* hepatic diseases\n* lower limb orthopedic hurting","35 Years","65 Years",{"count":87,"type":21},[24],"the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population",[164,27],"Hemolysis","2025-01-29",{"date":167,"type":38},"2025-02-04",{"date":169,"type":38},"2024-11-06",{"date":171,"type":21},"2025-03-06",{"name":173,"class":76},"Cairo University",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":46},"100553060","blood-changes-after-exercise-in-restless-legs-syndrome-100553060","NCT06481176","Blood Changes After Exercise in Restless Legs Syndrome","Proteomic Response to Exercise in Adults With Restless Legs Syndrome","PEARLS","Inclusion Criteria:\n\n* age 18 years or older;\n* diagnosis of RLS;\n* presence of moderate-to-severe RLS (IRLS score\\>15);\n* currently untreated RLS;\n* being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months;\n* ability to walk without assistance (does not use a cane\u002Fwalker\u002Fwheelchair for mobility;\n* willing to complete outcome measures and complete the exercise program\n\nExclusion Criteria:\n\n* present with a condition that can mimic RLS or cause secondary RLS (e.g., iron deficiency anemia, radiculopathy, peripheral edema, peripheral neuropathy, diabetes);\n* are at moderate or high risk for undertaking strenuous or maximal exercise",{"count":110,"type":21},[24],"The goal of this clinical trial is to learn how exercise changes molecules in the blood in people with restless legs syndrome (RLS) to better understand the cause(s) of RLS. The main questions the investigators aim to answer are:\n\nHow does long-term exercise change proteins in the blood?\n\nHow does a single exercise session change proteins in the blood?\n\nThe investigators will compare long-term exercise to no exercise to see if the changes in proteins are specific to exercise.\n\nParticipants will complete an exercise test and provide blood samples before and after the exercise test. Participants will be randomized (like the flip of a coin) in to either the exercise or no-exercise group for 12 weeks and then complete the exercise test and blood samples again at the end.",[27],[187,188],"Exercise","Proteomics","2024-11-25",{"date":191,"type":38},"2024-11-27",{"date":193,"type":38},"2024-10-21",{"date":195,"type":21},"2026-12",{"name":197,"class":76},"Stanford University",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":4},"100564601","phase-1-a-randomized-placebo-controlled-trial-of-prednisone-in-refractory-restless-legs-syndrome-a-pilot-study-100564601","NCT06631300","A Randomized, Placebo-controlled Trial of Prednisone in Refractory Restless Legs Syndrome: a Pilot Study","PrRLS","Inclusion Criteria:\n\n* Outpatient\n* Refractory RLS defined as restless legs unresponsive to monotherapy with tolerable doses of first-line agents due to reduction in efficacy, augmentation, or adverse effects\n* IRLS score greater than 15\n\nExclusion Criteria:\n\n* Pregnancy\n* Prescence of iron deficiency anemia\n* History of Diabetes Mellitus Type 1 and Type 2\n* History of uncontrolled hypertension\n* Presence of immunosuppression (HIV or currently taking immunosuppressants)\n* Any prior adverse reaction to glucocorticoids\n* History of dementia or major psychiatric diseases with psychosis\n* Lack of ability to understand the experimental protocol and to adequately communicate in English",{"count":20,"type":21},[207,208],"PHASE1","PHASE2","Restless legs syndrome is a common sleep-related movement disorder that affects up to 15% of the population in North America, characterized by an uncomfortable urge to move the legs. This has been associated with poor quality of sleep and overall decreased quality of life. Chronic inflammation has been implicated as a key mediator of the low intracranial iron stores that characterize restless legs syndrome (RLS). Current medications for RLS target concomitant low serum iron levels or the dopaminergic pathway, but none target the inflammatory pathway. A novel therapy that focuses on inflammation would allow for additional research into the role of inflammation and cytokines in the development of RLS, and potentially unlock a new class of medications to treat patients with RLS. A small amount of prior evidence suggest that RLS symptoms improve with steroids, with associated improved quality of life, and with decreasing hepcidin levels as a biomarker of symptom severity. This pilot study, using an RCT design, serves to assess the efficacy of glucocorticoids in the alleviation of RLS symptoms, which would further anchor the association between RLS, inflammation, and one of its potential mediators - hepcidin. By giving a prednisone taper versus placebo, this study primarily aims to assess the effect of glucocorticoids on 1) decreasing RLS symptom severity. This study also aims to measure 2) objectively measured improvement in sleep, 3) changes in baseline and post-treatment hepcidin levels, and 4) prevalence of adverse events including psychosis and weight gain. RLS can be a debilitating disease and several non-traditional medications have been tested but with unequivocal results. Glucocorticoids may be an easily accessible and affordable key to better quality of life for RLS patients, especially those with refractory RLS.",[27],[212,213,214],"refractory rls","rls","restless legs syndrome","2024-10-06",{"date":217,"type":38},"2024-10-08",{"date":219,"type":21},"2024-10-01",{"date":221,"type":21},"2025-12-31",{"name":223,"class":76},"Scripps Health",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":84,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":46},"100509037","the-application-of-wide-pulse-high-frequency-neuromuscular-electrical-stimulation-in-disorders-associated-with-motoneuron-hyperexcitability-100509037","NCT05908214","The Application of Wide Pulse High Frequency Neuromuscular Electrical Stimulation in Disorders Associated With Motoneuron Hyperexcitability","MnHyperex","STROKE PATIENTS:\n\n* Diagnosis of first-ever stroke (ischemic or hemorrhagic) with unilateral motor deficits from at least 6 months. Stroke will have to be confirmed from medical records and\u002For radiological imaging (CT scan or MRI)\n* Inadequate ankle control during gait defined as ankle dorsiflexion less than 5° during stance phase and 0° during swing phase; 0° = ankle neutral position)\n* Passive range of motion of ankle dorsiflexion at least to neutral position\n* Ability to walk at least 10 m with or without assistive devices\n* Spasticity at the triceps surae (either soleus and\u002For gastrocnemii) considered as a Modified Ashworth Sore ≥1\n* Being available for the study period and willing to participate\n* No contraindication to neuromuscular electrical stimulation\n\nContraindications for stroke patients:\n\n* Surface sensory loss of affected lower leg (defined as incapacity to feel the 60-g touch using the Semmes-Weinstein monofilament test)\n* Patients unable to understand indications or to provide informed consent\n* A history of orthopedic or other neurological disorders affecting walking function\n* A history of surgery to correct drop foot (ankle fixation)\n* Patients under antispastic medication (baclofen, tizanidine, tolperisone, benzodiazepines, dantrolene or botulinum toxin to the plantar flexor muscles in the last 6 months).\n\nPEOPLE PRONE TO MUSCLE CRAMPS:\n\n* Reporting nocturnal muscle cramps (the assessment will be done through a questionnaire)\n* Not being treated for muscle cramps\n* Being available for the study period and willing to participate\n* No contraindication to neuromuscular electrical stimulation\n\nPATIENTS WITH RESTLESS LEGS SYNDROME:\n\nTo be included in the study, RLS patients will have to satisfy the Diagnostic criteria for RLS published by the International Restless Legs Syndrome StudyGroup (IRLSSG). All five key clinical features are required for the diagnosis:\n\n* An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. Sometimes the urge to move is present without the uncomfortable sensations, and sometimes the arms or other body parts are involved in addition to the legs.\n* The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.\n* The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.\n* The urge to move or unpleasant sensations are worse in the evening or night than during the day, or only occur in the evening or night. When symptoms are severe, the worsening at night may not be noticeable but must have been previously present.\n* Symptoms are not solely accounted for by another medical or behavioral condition, such as leg cramps or habitual foot tapping.\n* No contraindication to neuromuscular electrical stimulation\n\nThey will also have to satisfy the following criteria:\n\n* Diagnosis of primary RLS corresponding to:\n\n  1. The presence of periodic limb movements\n  2. A dopaminergic treatment response\n  3. The presence of RLS in first-degree relatives\n  4. A lack of profound daytime sleepiness\n* Being available for the study period and willing to participate\n\nHEALTHY PARTICIPANTS:\n\n* No neurological disease\n* No contraindication to neuromuscular electrical stimulation\n* Being available for the study period and willing to participate",{"count":232,"type":21},110,[24],"In the present project, the investigators aim at proposing innovative ways of investigating spinal motoneuron hyperexcitability to counteract the associated impairments by using wide pulse high frequency neuromuscular electrical stimulation (WPHF NMES) in various populations. The investigators will use WPHF NMES contractions as a model to gain insights into the mechanisms underlying muscle cramps, restless legs syndrome or stroke-induced spasticity as there is evidence that they share common underlying mechanisms. The investigators will then use WPHF NMES as a training modality to improve plantar flexor neuromuscular function in stroke patients by taking advantage of their motoneuronal hyperexcitability.",[236,237,27,238],"Stroke","Cramp","Healthy Volunteers",[240,241,242],"muscle strength","persistent inward current","training","2023-11-27",{"date":245,"type":38},"2023-11-28",{"date":247,"type":38},"2023-10-01",{"date":249,"type":21},"2026-12-31",{"name":251,"class":76},"University of Lausanne",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":260,"enrollmentInfo":261,"targetDuration":263,"studyType":134,"phases":4,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":46},"100463950","mainz-register-of-patients-with-sleep-disorders-100463950","NCT05321355","Mainz Register of Patients With Sleep Disorders","Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)","MAINZ-SLEEPREG","Inclusion Criteria:\n\n* patients with narcolepsy\n* patients with other neurological sleep disorders\n\nExclusion Criteria:\n\n* patients aged \\\u003C18 years\n* patients who cannot provide informed consent and don't have a legal guardian","120 Years",{"count":262,"type":21},500,"3 Years","Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.",[266,267,268,269,270,271,272,27,273],"Sleep Disorder","Sleep Disorder Parasomnia","Narcolepsy","Sleep Apnea","Insomnia","Somnambulism","Idiopathic Hypersomnia","REM Behavior Disorder","2022-09-11",{"date":276,"type":38},"2022-09-15",{"date":278,"type":38},"2022-02-01",{"date":280,"type":21},"2030-01-31",{"name":282,"class":76},"Johannes Gutenberg University Mainz",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":46},"100442679","clinical-features-associated-with-restless-legs-syndrome-100442679","NCT05044520","Clinical Features Associated With Restless Legs Syndrome.","Clinical Features Associated With Restless Legs Syndrome : Clin-RLS","Clin-RLS","Inclusion criteria:\n\n* Adults subjects\n* Restless legs syndrome diagnosis\n* Member of the restless legs syndrome association\n* French speaking\n* Able to understand the study\n* Signed written informed consent\n* Affiliated to social security\n\nExclusion criteria:\n\n\\- Vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship)",{"count":292,"type":21},2000,"Restless legs syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs at night when at rest. RLS can lead to a sleep deprivation, increased falling risk, daytime sleepiness, depression and decreased quality of life. Dopamine agonists, alpha-2-delta ligands and opiates are key medications for RLS. The natural course of RLS is very heterogeneous with a risk of increasing the severity of symptoms over the years despite the use of drugs and recommended dosages. Many comorbidities can make RLS worse. Augmentation syndrome is the main complication of dopamine agonists. However, only a few studies have addressed the clinical, biological and pharmacological factors associated with the evolution of the severity of RLS. The objective of this study is to assess the evolution of RLS symptoms severity as function of RLS phenotype, comorbidities and RLS medication, in large cohort of members of the French RLS association and other European RLS association.",[27],[296,297,298,299,300],"Restless legs syndrome","Augmentation syndrome","Dopamine agonists","Alpha 2 delta ligands","Opiates","2021-09-18",{"date":303,"type":38},"2021-09-24",{"date":305,"type":38},"2021-09-01",{"date":307,"type":21},"2027-09-01",{"name":100,"class":76}]