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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02253498

Enrollment

Registered

2014-10-01

Start date

2016-12-31

Completion date

2018-12-31

Last updated

2016-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DEVICEdeep brain stimulation (DBS)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Modified Rush Video Rating Scale (mRVRS)	12 month

Secondary

Measure	Time frame
Tourette Syndrome Symptom List (TSSL)	12 month
SF-36	12 month

Contacts

Primary ContactJia Fumin, PhD

pins_medical@163.com010-59361265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026