[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100469837":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study population","EXPERIMENTAL","12 patients with neck and upper limb pain who have failed multidisciplinary treatment and are candidates for cervical medullary stimulation will be included.",[13],"Device: Implantation of the WAVEWRITER ALPHA ™ device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Implantation of the WAVEWRITER ALPHA ™ device","The 12 patients will be implanted by the WAVEWRITER ALPHA ™ device. Then, the order of the three stimulation modes will be randomly selected and will be composed of 5 modalities:\n\n* tonic stimulation \"LF\": In tonic mode, the electrical stimulation of the sensory fibres of the posterior cords of the spinal cord induces local paresthesias\n* high frequency\" stimulation (1000 Hz) \"High Frequency\".\n* stimulation in bursts (or \"Burst\")",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Sylvie RAOUL","CONTACT","02 40 16 50 80","sylvie.raoul@chu-nantes.fr",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"CHU de Nantes","RECRUITING","Nantes","44093","France","FR",{"type":36,"coordinates":37},"Point",[38,39],-1.55336,47.21725,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":20,"phoneExt":20,"email":20},"Sylvie Raoul, MD",{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100469837","medullary-stimulation-for-the-treatment-of-refractory-neck-pain-s2m-100469837",false,"NCT05398003","Medullary Stimulation for the Treatment of Refractory Neck Pain (S2M)","Evaluation of Multimodal Medullary Stimulation in Refractory Neck and Upper Limb Pain","S2M","Inclusion criteria:\n\n* Patients aged 18 to 85 years\n* Patients with chronic neck and upper limb pain (according to HAS criteria for spinal cord stimulation)\n* Patients must be able to give informed consent and must have signed an informed consent\n* Affiliation to the health insurance\n* A negative pregnancy test for women of childbearing potential\n* Women of childbearing potential must use an appropriate contraceptive method(s) during the clinical trial\n\nNon-inclusion criteria:\n\n* Drug or alcohol abuse\n* Any medical or psychological problem that may interfere with the proper conduct of the study protocol (e.g., cancer with limited life expectancy)\n* Difficulty with follow-up\n* Pregnant or breastfeeding women\n* Women of childbearing potential who are not using contraception\n* Adults under legal protection (guardianship, curatorship, \"sauvegarde de justice\") or deprived of liberty\n* Exclusion period for another study\n* Participation in another interventional study whose primary objective is based on pain.\n\nExclusion criteria:\n\n\\- 7-day post-implantation test phase negative","ALL","18 Years","85 Years",{"count":58,"type":59},12,"ESTIMATED","INTERVENTIONAL",[62],"NA","Number of centres planned : 1 (CHU Nantes)\n\nDesign : Randomized, Prospective\n\nPlanning of the study :\n\n* Total duration: 34 months\n* Recruitment period: 24 months.\n* Follow-up time per patients : 7-10 months\n\nExpected number of cases : 12\n\nTreatment, procedure, combination of procedures under consideration :\n\nDuring the study, patients will be implanted with the WAVEWRITER ALPHA™ system with the objective of decreasing patient pain with a spinal cord stimulation mode.\n\nThere will be a random draw on the order of the stimulation program:\n\n* the tonic stimulation \"LF\": In tonic mode, the electrical stimulation of the sensory fibers of the posterior cords of the spinal cord induces local paresthesias\n* burst stimulation (or \"burst\")\n* high frequency\" stimulation (1000 Hz) \"High frequency: HF\".\n* combined tonic + burst stimulation\n* combined tonic + high frequency stimulation",[65],"Pain, Intractable",[67,68],"Medullary stimulation","refractory neck pain","2024-11-14",{"date":71,"type":72},"2024-11-18","ACTUAL",{"date":74,"type":72},"2022-11-23",{"date":76,"type":59},"2026-09-23",{"name":5,"class":6},1]