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

Beijing Pins Medical

Status and phase: Unknown; Early Phase 1

Conditions: Tourette Syndrome

Treatments: Device: deep brain stimulation (DBS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02253498

PINS-009

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Deep Brain Stimulation

Experimental group

Description:

Deep Brain Stimulation is on

Treatment:

Device: deep brain stimulation (DBS)

Sham Stimulation

Sham Comparator group

Description:

placebo

Treatment:

Device: deep brain stimulation (DBS)