NCT02253498

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Dec 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
2.2 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 14, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

September 29, 2014

Last Update Submit

October 13, 2016

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

  • Modified Rush Video Rating Scale (mRVRS)

    12 month

Secondary Outcomes (2)

  • Tourette Syndrome Symptom List (TSSL)

    12 month

  • SF-36

    12 month

Study Arms (2)

Deep Brain Stimulation

EXPERIMENTAL

Deep Brain Stimulation is on

Device: deep brain stimulation (DBS)

Sham Stimulation

SHAM COMPARATOR

placebo

Device: deep brain stimulation (DBS)

Interventions

deep brain stimulation (DBS)DEVICE
Also known as: Implanted device
Deep Brain StimulationSham Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is aged 18 or older
  • Patient Group with Tourette's syndrome, Diagnosis of Tourette Syndrome by DSM-IV

You may not qualify if:

  • Major Depressive Episode within the previous 6 months
  • Schizophrenia or other psychotic disorder.Participate in other clinical trial;
  • Has a life expectancy of \< 1 year.
  • The investigator and/or enrollment review committee, would preclude participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tourette Syndrome

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Li Luming, PhD

    Tsinghua University

    STUDY CHAIR

Central Study Contacts

Jia Fumin, PhD

CONTACT

010-59361265pins_medical@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 14, 2016

Record last verified: 2016-05