[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marshall Holland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Restless Leg Syndrome (RLS)","Spinal Cord Stimulation (SCS)",[30,31],"RLS","SCS","NOT_YET_RECRUITING","2026-08-18",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":21},"2026-10",{"date":40,"type":21},"2034-10",{"name":42,"class":43},"Marshall Holland","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100603067","the-effect-of-transcutaneous-vagal-nerve-stimulation-tvns-on-cerebral-vasospasm-secondary-to-aneurysmal-subarachnoid-hemorrhage-100603067","NCT07131696","The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage","Inclusion Criteria:\n\n* Provision of signed and dated informed consent\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or Female\n* 18-65 years of age\n* Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage\n* Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage\n* For females of reproductive potential: negative pregnancy test at time of treatment.\n* Plan to undergo standard of care treatment and follow-up\n\nExclusion Criteria:\n\n* Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)\n* Does not provide consent\n* Posterior circulation aneurysmal subarachnoid hemorrhage\n* Initial aneurysm treatment after post bleed day 1","65 Years",{"count":53,"type":21},10,[24],"The significance of developing a safe and effective therapy for aneurysmal subarachnoid hemorrhage (aSAH) patients suffering cerebral vasospasm (CVS) cannot be overstated. Vasospasm - a clamping down of normal arteries in the days following rupture - remains incredibly challenging to treat.1,2 Current drugs and minimally invasive surgical therapies are helpful, yet woefully insufficient. Symptomatic cerebral vasospasm afflicts about 30% of aneurysmal subarachnoid hemorrhage patients and nearly half will go on to suffer a stroke, despite aggressive medical care.1-3 The autonomic nervous system is a balance between sympathetic (fight or flight) and parasympathetic (rest and digest) influence with sympathetic overactivity and inflammation shown to play an important role in the development and severity of cerebral vasospasm.4,5,17-20 Prior studies of autonomic nervous system neuromodulation highlight its promise as a promising potential avenue to improve morbidity and mortality from CVS in aSAH.6-15 Despite progress, continued high levels of CVS morbidity and mortality stress the urgent need for exploration of neuromodulation therapy.\n\nIn this proposal, the study team will modulate the autonomic nervous system function in aSAH patients using transcutaneous vagal nerve stimulation (tVNS). tVNS involves placement of a stimulation electrode on the external ear to non-invasively stimulate a branch of the vagal nerve and increase parasympathetic influence. This device has FDA approval for epilepsy and cluster headache.\n\nThe study hypothesis is that neuromodulation of the autonomic nervous system with tVNS (increasing parasympathetic influence) reduces sympathetic overactivity and inflammation in aSAH resulting in decreased morbidity of CVS.",[57,58,59,60],"Aneurysmal Subarachnoid Hemorrhage","Vasospasm, Cerebral","Transcutaneous Vagal Nerve Stimulation (tVNS)","Endovascular Treatment",[62,63,64],"CVS","aSAH","tVNS","RECRUITING","2026-08-07",{"date":68,"type":36},"2026-08-11",{"date":70,"type":36},"2026-02-06",{"date":72,"type":21},"2029-09",{"name":42,"class":43},""]