[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543833":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":46,"collaborators":20,"id":48,"slug":20,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Treatment-refractory Tourette's syndrome (TR-TS)","EXPERIMENTAL","Patients will undergo bilateral DBS lead implantation.",[13],"Device: Deep Brain Stimulation (DBS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Deep Brain Stimulation (DBS)","The DBS lead is stereotactically introduced into the target in the brain (GPi, amGPi, pvGPi, Cm-Spv-Voi, Cm-Voi, NA-ALIC, or other unreported nuclei targets) 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",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Xiaolei Liu, MD & PhD","CONTACT","+86 10 83198650","ring@vip.163.com",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Wenfeng Zhao, MD","fengfeng_zw@ccmu.edu.cn",[35],{"facility":36,"status":20,"city":37,"state":20,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":20},"Xuanwu Hospital, Capital Medical University","Beijing","100053","China",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100543833",false,"NCT06361004","Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome","Investigating the Impact of Deep Brain Stimulation (DBS) in 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":58,"type":59},60,"ESTIMATED","INTERVENTIONAL",[62],"NA","The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) in patients with Treatment-refractory Tourette's syndrome (TR-TS) implantation targeting the Antero-medial globus pallidus interna (GPi), Antero-medial globus pallidus interna (amGPi), Postero-ventrolateral GPi (pvGPi), Centromedian nucleus, substantia periventricularis and nucleus ventro-oralis internus (Cm-Spv-Voi), Centre median nucleus and nucleus ventro-oralis (Cm-Voi), or Nucleus Accumbens\u002F Anterior Limb of Internal Capsule (NA-ALIC), or other unreported nuclei targets.",[65],"Tourette's Syndrome",[67],"TS, DBS","NOT_YET_RECRUITING","2024-04-08",{"date":71,"type":72},"2024-04-11","ACTUAL",{"date":74,"type":59},"2024-04-20",{"date":76,"type":59},"2029-12-31",{"name":5,"class":6},1]