Back to resultsThe Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
Primary Purpose
Tourette Syndrome
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
deep brain stimulation (DBS)
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Deep Brain Stimulation
Sham Stimulation
Arm Description
Deep Brain Stimulation is on
placebo
Outcomes
Primary Outcome Measures
Modified Rush Video Rating Scale (mRVRS)
Secondary Outcome Measures
Tourette Syndrome Symptom List (TSSL)
SF-36
Full Information
NCT ID
NCT02253498
First Posted
September 29, 2014
Last Updated
October 13, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02253498
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Deep Brain Stimulation is on
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Arm Description
placebo
Intervention Type
Device
Intervention Name(s)
deep brain stimulation (DBS)
Other Intervention Name(s)
Implanted device
Primary Outcome Measure Information:
Title
Modified Rush Video Rating Scale (mRVRS)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Tourette Syndrome Symptom List (TSSL)
Time Frame
12 month
Title
SF-36
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fumin, PhD
Phone
010-59361265
Email
pins_medical@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Luming, PhD
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
We'll reach out to this number within 24 hrs