[{"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:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100636903","study-on-the-efficacy-of-spinal-cord-stimulation-in-patients-with-severe-refractory-primary-or-secondary-rls-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":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Restless Leg Syndrome (RLS)",[27,29,30],"Neurostimultor for Restless Leg Syndorme","Neurostimulator","NOT_YET_RECRUITING","2026-04-30",{"date":34,"type":35},"2026-05-06","ACTUAL",{"date":37,"type":21},"2026-06-01",{"date":39,"type":21},"2029-02-14",{"name":41,"class":42},"Clinica ARS Medica","OTHER",2,""]