Brief Title
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
Official Title
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
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 Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Modified Rush Video Rating Scale (mRVRS)
Secondary Outcome
Tourette Syndrome Symptom List (TSSL)
Condition
Tourette Syndrome
Intervention
deep brain stimulation (DBS)
Study Arms / Comparison Groups
Deep Brain Stimulation
Description: Deep Brain Stimulation is on
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
December 2016
Completion Date
December 2018
Primary Completion Date
December 2018
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Li Luming, PhD, 010-59361265, [email protected]
Administrative Informations
NCT ID
NCT02253498
Organization ID
PINS-009
Responsible Party
Sponsor
Study Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
Study Sponsor
Li Luming, PhD, Study Chair, Tsinghua University
Verification Date
May 2016