[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652925":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":11,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SCS Implant","EXPERIMENTAL",null,[13],"Device: Spinal Cord Stimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Spinal Cord Stimulation","Implantation of the FDA-approved Saluda Medical Evoke® Spinal Cord Stimulation System with Smartloop® Technology. Two percutaneous epidural leads will be implanted in the thoracic spine (T7-T10 region) and programmed to provide chronic spinal cord stimulation for treatment of severe RLS symptoms.",[9],[21],{"name":22,"affiliation":5,"role":23},"Marshall Holland, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Chris Gonzalez","CONTACT","2059964318","clgonzalez@uabmc.edu",[31],{"facility":32,"status":11,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"UAB Hospital","Birmingham","Alabama","35233","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-86.80249,33.52066,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Marshall Holland","Assistant Professor of Neurosurgery",[51],{"name":52,"class":53},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100652925","neuromodulation-to-overcome-severe-restless-legs-syndrome-100652925",false,"NCT07780032","Neuromodulation to Overcome Severe Restless Legs Syndrome","Neuromodulation to Overcome Severe Restless Legs Syndrome (NO RLS)","NO RLS","Inclusion Criteria:\n\n1. Age \\>18 years and older.\n2. Received a medical diagnosis of RLS via first screening with Cambridge Hopkins- RLS questionnaire and confirmed via Hopkins-Hening Diagnostic questionnaire.\n3. IRLS Scale score ≥ 21 (classified as severe) and received a determination of treatment refractory RLS or inadequate response to standard medical treatment for RLS by a sleep medicine physician.\n4. RLS symptoms occur ≥ 3 nights per week.\n5. Willing and able to comply with study procedures.\n6. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years.\n2. Neuropathic pain, other than RLS on DN4 questionnaire.\n3. Any mental or physical limitation that would prevent completing and of the study protocols.\n4. Active medical implant in the body (i.e., pacemaker).\n5. History of prior SCS trial or implantation.\n6. Currently using another device to treat RLS.\n7. Unable or unwilling to comply with study protocols.\n8. Other medical conditions that would put the subject at risk as determined by the investigators.\n9. Pregnant, breastfeeding, or trying to become pregnant.\n10. Currently participating or plans to participate in any other investigational clinical evaluation during the study period that may, in the opinion of the investigators, affect RLS.\n11. Ferritin \\\u003C 50 ng\u002FmL (excludes iron deficiency).\n12. HgA1C \\> 7.5 (excludes unstable diabetes melilitus)\n13. One or more of the following diagnoses: spinal cord injury or prior spinal surgery, severe peripheral neuropathy, severe psychiatric or cognitive disorder that may interfere with study participation, history of drug or alcohol abuse within the past year, epilepsy or seizure disorder, current active or chronic infection other than common cold, malignancy within the past 5 years (not including basal cell or squamous cell skin cancer), severe movement disorder (i.e., Parkinson's disease), deep vein thrombosis, multiple sclerosis, known or suspected allergy to SCS materials.","ALL","18 Years",{"count":65,"type":66},15,"ESTIMATED","INTERVENTIONAL",[69],"NA","This prospective, single-center, first-in-indication feasibility study will evaluate the safety and preliminary effectiveness of spinal cord stimulation (SCS) for the treatment of severe, treatment-refractory primary Restless Legs Syndrome (RLS). Participants will undergo implantation of the Saluda Medical Evoke® Spinal Cord Stimulation System and will be followed for 24 months with clinical, neurophysiological, and patient-reported outcome assessments.",[72,73],"Restless Leg Syndrome (RLS)","Spinal Cord Stimulation (SCS)",[75,76],"RLS","SCS","NOT_YET_RECRUITING","2026-08-18",{"date":80,"type":81},"2026-08-21","ACTUAL",{"date":83,"type":66},"2026-10",{"date":85,"type":66},"2034-10",{"name":48,"class":6},1]