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

Sponsor
Beijing Pins Medical Co., Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02253498
Collaborator
Beijing Tiantan Hospital (Other)
20
Enrollment
2
Arms
24
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: deep brain stimulation (DBS)
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deep Brain Stimulation

Deep Brain Stimulation is on

Device: deep brain stimulation (DBS)
Other Names:
  • Implanted device

    		•
    Sham Comparator: Sham Stimulation

    placebo

    Device: deep brain stimulation (DBS)
    Other Names:
  • Implanted device

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Modified Rush Video Rating Scale (mRVRS) [12 month]

    Secondary Outcome Measures

    1. Tourette Syndrome Symptom List (TSSL) [12 month]

    2. SF-36 [12 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beijing Pins Medical Co., Ltd
    • Beijing Tiantan Hospital

    Investigators

    • Study Chair: Li Luming, PhD, Tsinghua University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Pins Medical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT02253498
    Other Study ID Numbers:
    • PINS-009
    First Posted:
    Oct 1, 2014
    Last Update Posted:
    Oct 14, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Tourette Syndrome
    Syndrome

    Study Results

    No Results Posted as of Oct 14, 2016