NCT02253498UnknownEarly Phase 1
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
Conditions
Trial Snapshot
- Phase
- Early Phase 1
- Enrollment
- 20
- Primary Endpoint
- Modified Rush Video Rating Scale (mRVRS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Modified Rush Video Rating Scale (mRVRS)
Time Frame: 12 month
Secondary Outcomes
- SF-36(12 month)
- Tourette Syndrome Symptom List (TSSL)(12 month)
Investigators
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