[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636903":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":71,"collaborators":25,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":97,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Clinica ARS Medica","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment phase: Sham-stimulation","PLACEBO_COMPARATOR","After IPG implantation Burst-SCS is turned on in all participants for 2.5. Then, they will again be double-blind randomized to the 2 treatment orders for 2 weeks per stimulation mode (Sham stimulation or SCS) as fcollows:\n\n* Double-blind randomization to the following alternating treatment modes:\n* 14 days Sham-stimulation + 14 days SCS\n* 14 days SCS + 14r days Sham-stimulation",[13],"Device: Sham stimulation",{"label":15,"type":16,"description":11,"interventionNames":17},"Treatment phase: SCS-stimulation","ACTIVE_COMPARATOR",[18],"Device: Spinal cord stimulation (SCS)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Spinal cord stimulation (SCS)","Burst SCS, a specific spinal cord stimulation waveform that delivers pulses in clusters separated by brief periods without stimulation, is chosen over other modalities due to its demonstrated ability to modulate both the sensory and affective components of pain and discomfort. Unlike traditional tonic stimulation, Burst SCS delivers stimulation patterns that more closely resemble natural neuronal firing, and may provide effective symptom relief without inducing paresthesia.",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham stimulation","For the Sham stimulation condition, the amplitude of the spinal cord stimulation will be set to zero.",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Eva Koetsier, PD MD PhD","CONTACT","+41 (0)91 611 64 82","eva.koetsier@hin.ch",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Mauro Manconi, MD PhD","+41 (0)91 811 68 25","mauro.manconi@eoc.ch",[41,57],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Clinica Ars Medica","Gravesano","Canton Ticino","6929","Switzerland","CH",{"type":49,"coordinates":50},"Point",[51,52],8.91832,46.04208,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":34,"phoneExt":25,"email":35},"Eva Koetsier, MD PhD",{"facility":58,"status":25,"city":59,"state":44,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Sleep Center, Neurocenter of Southern Switzerland - EOC","Lugano","6900",{"type":49,"coordinates":62},[63,64],8.96004,46.01008,{"lat":64,"lon":63},[67,68],{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},{"name":69,"role":70,"phone":25,"phoneExt":25,"email":25},"Sandra Hackethal, MD","SUB_INVESTIGATOR",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Eva Koetsier","Clinical Professor Eva Koetsier, PhD, LL.M, Specialist in Anaesthesiology and Interventional Pain Management","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":86,"type":87},15,"ESTIMATED","INTERVENTIONAL",[90],"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.",[93],"Restless Leg Syndrome (RLS)",[93,95,96],"Neurostimultor for Restless Leg Syndorme","Neurostimulator","NOT_YET_RECRUITING","2026-04-30",{"date":100,"type":101},"2026-05-06","ACTUAL",{"date":103,"type":87},"2026-06-01",{"date":105,"type":87},"2029-02-14",{"name":5,"class":6},2]