The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
Early Phase 1
- Conditions
- Tourette Syndrome
- Registration Number
- NCT02253498
- Lead Sponsor
- Beijing Pins Medical Co., Ltd
- Brief Summary
The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Tourette Syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Subject is aged 18 or older
- Patient Group with Tourette's syndrome, Diagnosis of Tourette Syndrome by DSM-IV
Exclusion Criteria
- Major Depressive Episode within the previous 6 months
- Schizophrenia or other psychotic disorder.Participate in other clinical trial;
- Has a life expectancy of < 1 year.
- The investigator and/or enrollment review committee, would preclude participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Modified Rush Video Rating Scale (mRVRS) 12 month
- Secondary Outcome Measures
Name Time Method SF-36 12 month Tourette Syndrome Symptom List (TSSL) 12 month