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

NCT ID: NCT02253498

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Tourette Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Deep Brain Stimulation

Deep Brain Stimulation is on

Group Type EXPERIMENTAL

deep brain stimulation (DBS)

Intervention Type DEVICE

Sham Stimulation

placebo

Group Type SHAM_COMPARATOR

deep brain stimulation (DBS)

Intervention Type DEVICE

Interventions

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deep brain stimulation (DBS)

Intervention Type DEVICE

Other Intervention Names

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Implanted device

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Luming, PhD

Role: STUDY_CHAIR

Tsinghua University

Central Contacts

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Jia Fumin, PhD

Role: CONTACT

010-59361265

Other Identifiers

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PINS-009

Identifier Type: -

Identifier Source: org_study_id

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