protocolSection identificationModule nctId: NCT06361004, orgStudyIdInfo id: DBS for TR-TS, briefTitle: Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: 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/ Anterior Limb of Internal Capsule (NA-ALIC), or other unreported nuclei targets., conditionsModule conditions: Tourette's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients with Treatment-refractory Tourette's syndrome (TR-TS), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Deep Brain Stimulation (DBS), outcomesModule primaryOutcomes measure: Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 6 months, secondaryOutcomes measure: YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12., secondaryOutcomes measure: YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12., secondaryOutcomes measure: YGTSS: remission, and response rate, secondaryOutcomes measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12., secondaryOutcomes measure: Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score., secondaryOutcomes measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months., secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12., secondaryOutcomes measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S), secondaryOutcomes measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12., secondaryOutcomes measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L., secondaryOutcomes measure: Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12., secondaryOutcomes measure: Safety as indicated by the number of Adverse Events: Week 2, Month 3, Month 6, and Month 12., secondaryOutcomes measure: Change from baseline in the Verbal Fluency Test (COWAT), secondaryOutcomes measure: Change from baseline in the Trailmaking Test A&B, secondaryOutcomes measure: Change in Rey-Osterrieth Complex Figure Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, zip: 100053, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False