[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576456":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":48,"collaborators":20,"id":50,"slug":20,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment-refractory Tourette's Syndrome (TR-TS)","EXPERIMENTAL","Patients will undergo bilateral RNS lead implantation.",[13],"Device: Responsive Neurostimulation (RNS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Responsive Neurostimulation (RNS)","The RNS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Hongxing Wang, MD & PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+861083198650","wanghongxing@xwh.ccmu.edu.cn",{"name":31,"role":27,"phone":28,"phoneExt":20,"email":32},"Huang Wang, MD","wanghuang1118@163.com",[34],{"facility":35,"status":36,"city":37,"state":20,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Xuanwu Hospital, Capital Medical University","RECRUITING","Beijing","100053","China",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100576456",false,"NCT06785532","Effect of RNS in Treatment-refractory Tourette's Syndrome","Investigating the Effect of Responsive Neurostimulation (RNS) in Patients with Treatment-refractory Tourette's Syndrome (TR-TS)","Inclusion Criteria:\n\n1. aged 18-65;\n2. able to provide written informed consent;\n3. have a diagnosis of Tourette's syndrome according to the Statistical Manual of Mental Disorders-Fourth Edition-Text Revised (DSM-IV-TR) criteria and confirmed by the Mini-International Neuropsychiatric Interview Chinese version 5.0;\n4. with a YGTSS of at least 35 for at least 12 months before surgery, while YGTSS- Total Motor≥15;\n5. must have failed conventional medical treatment at adequate therapeutic doses of three classes of medication lasting for at least three months;\n6. must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful;\n7. have been on stable comorbid conditions without suicidal ideation for at least six months.\n\nExclusion Criteria:\n\n1. presence of other psychotic disorders;\n2. have a treatment history that includes electroconvulsive therapy (ECT), modified electroconvulsive therapy (MECT), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), DBS, and transcranial magnetic stimulation (TMS);\n3. presents a suicide risk (defined as a HAMD-17 score of ≥3 on suicide-related items);\n4. experience difficulty in effectively communicating with investigators;\n5. with a history of traumatic brain injury (TBI);\n6. with intracranial or cardiovascular stents;\n7. substance abuse within the past six months;\n8. unstable neurological or coagulation disorders;\n9. women who are pregnant, lactating, or of childbearing potential who refuse the use of reliable contraception during the study;\n10. have been involved in other clinical studies within three months before enrollment in this study;\n11. any conditions considered by the study group.","ALL","18 Years","65 Years",{"count":60,"type":61},10,"ESTIMATED","INTERVENTIONAL",[64],"NA","The study is to investigate the effect of personalized responsive neurostimulation (RNS) therapy guided by stereoelectroencephalography (SEEG) in patients with treatment-resistant Tourette's Syndrome (TR-TS).",[67],"Tourette Syndrome",[69],"TS, RNS","2025-01-19",{"date":72,"type":73},"2025-01-21","ACTUAL",{"date":75,"type":61},"2025-02-05",{"date":77,"type":61},"2029-12-31",{"name":5,"class":6},1]