The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome

Early Phase 1

• Conditions: Tourette Syndrome
• Interventions: Device: deep brain stimulation (DBS)

• 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

Study Timeline

• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Subject is aged 18 or older
2. Patient Group with Tourette's syndrome, Diagnosis of Tourette Syndrome by DSM-IV

Exclusion Criteria

1. Major Depressive Episode within the previous 6 months
2. Schizophrenia or other psychotic disorder.Participate in other clinical trial;
3. Has a life expectancy of < 1 year.
4. The investigator and/or enrollment review committee, would preclude participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	deep brain stimulation (DBS)	placebo
Deep Brain Stimulation	deep brain stimulation (DBS)	Deep Brain Stimulation is on

Primary Outcome Measures

Name	Time	Method
Modified Rush Video Rating Scale (mRVRS)	12 month

Secondary Outcome Measures

Name	Time	Method
Tourette Syndrome Symptom List (TSSL)	12 month
SF-36	12 month