[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Clinica ARS Medica\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100636903",false,"NCT07571733","Study on the Efficacy of Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS","A Double-Blind, Randomized, Sham-Controlled, Crossover Study on the Efficacy of Burst Spinal Cord Stimulation in Patients With Severe Refractory Primary or Secondary RLS: the REST-SCS Study","REST-SCS","Inclusion Criteria:\n\n* Male and female (all sexes) aged 18 years or older, inclusive;\n* Diagnosis of primary or secondary RLS;\n* Severe to very severe RLS defined as IRLS-RS score \\> 20;\n* Duration of RSL symptoms ≥ 6 months;\n* Insufficient symptom control achieved by and\u002For intolerance to established mono- or combination therapy of standard pharmacological treatment incl. patients in augmentation;\n* Stable pharmacologic therapy for RLS for at least 1 month;\n* A stable pattern of neurological symptoms;\n* Patients who are legally competent and able to understand the nature, scope and aim of the clinical trial;\n* Signed informed subject consent form\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to the materials of the device;\n* Concomitant use of psychoactive-drugs (e.g. benzodiazepines, antidepressants; wash-out period: at least 7 days or longer depending on half-life);\n* Co-morbid sleep disorders influencing sleep structure and nocturnal motor pattern (e.g. Narcolepsy, REM sleep behaviour disorder etc.);\n* Coagulopathy or oral anticoagulant therapy (except low-dose acetylsalicylic acid) in conditions that do not allow for a temporary discontinuation;\n* Active infection, systemic or localized;\n* Known immune deficiency;\n* Presence of spinal cord or peripheral nerve stimulators;\n* Any disease process or condition that may make the effect of the treatment difficult to evaluate (e.g. cancer with low life expectancy);\n* Severe psychiatric disorders (including substance abuse, major depression, and similar severe disorders known or suspected non-compliance) which could have a negative influence on successful treatment;\n* Inability to follow the procedures of the study, e.g. due to language problems, dementia, etc. of the participant;\n* Women who are pregnant or breast feeding;\n* Intention to become pregnant during the course of the study;","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"NA","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\u002For patients in augmentation, with a two-period-alternating treatment design.",[26],"Restless Leg Syndrome (RLS)",[26,28,29],"Neurostimultor for Restless Leg Syndorme","Neurostimulator","NOT_YET_RECRUITING","2026-04-30",{"date":33,"type":34},"2026-05-06","ACTUAL",{"date":36,"type":20},"2026-06-01",{"date":38,"type":20},"2029-02-14",{"name":40,"class":41},"Clinica ARS Medica","OTHER",2,""]