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

Tourette Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02253498
• Other study ID #: PINS-009
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 29, 2014
• Last updated: October 13, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: 010-59361265
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Device:
• deep brain stimulation (DBS)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rush Video Rating Scale (mRVRS)		12 month	Yes
Secondary	Tourette Syndrome Symptom List (TSSL)		12 month	Yes
Secondary	SF-36		12 month	Yes