- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02253498
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome
October 13, 2016 updated by: Beijing Pins Medical Co., Ltd
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jia Fumin, PhD
- Phone Number: 010-59361265
- Email: pins_medical@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is aged 18 or older
- Patient Group with Tourette's syndrome, Diagnosis of Tourette Syndrome by DSM-IV
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep Brain Stimulation
Deep Brain Stimulation is on
|
Other Names:
|
Sham Comparator: Sham Stimulation
placebo
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modified Rush Video Rating Scale (mRVRS)
Time Frame: 12 month
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tourette Syndrome Symptom List (TSSL)
Time Frame: 12 month
|
12 month
|
SF-36
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
September 29, 2014
First Submitted That Met QC Criteria
September 29, 2014
First Posted (Estimate)
October 1, 2014
Study Record Updates
Last Update Posted (Estimate)
October 14, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Syndrome
- Tourette Syndrome
Other Study ID Numbers
- PINS-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tourette Syndrome
-
Children's Hospital Medical Center, CincinnatiTourette Association of AmericaRecruitingTourette Syndrome | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tourette Syndrome, Modifier ofUnited States
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Ministry of Health, ItalyCompletedTourette Syndrome | Tourette's Syndrome | Tourette Disorder | Gilles de la Tourette SyndromeItaly
-
Tasly Pharmaceuticals, Inc.Not yet recruitingTourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States
-
Emalex Biosciences Inc.CompletedTourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States, Poland, France, Canada, Germany
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Vanderbilt University Medical CenterCompletedTourette Syndrome | Tourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States
-
Johns Hopkins UniversityCompletedTourette Syndrome in Children | Tourette Syndrome in Adolescence | Habit Reversal Training | TicUnited States
-
Tel Aviv Medical CenterUnknownTourette Syndrome in Children | Tourette Syndrome in Adolescence | Chronic Tic DisorderIsrael
-
Wake Forest University Health SciencesUniversity of Rochester; Tourette Association of AmericaRecruitingTourette Syndrome | Tics | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tic Disorder, ChildhoodUnited States
-
University of MinnesotaCompletedTourette Syndrome | Tic Disorders | Tics | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tic Disorder, Childhood | Tic, MotorUnited States
-
Max Planck Institute for Human Cognitive and Brain...Hannover Medical School; Leipzig University Medical CenterCompletedTourette Syndrome | Gilles de la Tourette SyndromeGermany
Clinical Trials on deep brain stimulation (DBS)
-
Ruijin HospitalActive, not recruitingMajor Depressive Disorder | Deep Brain StimulationChina
-
Beijing Pins Medical Co., LtdPeking Union Medical College HospitalCompleted
-
University of ChicagoMichael J. Fox Foundation for Parkinson's ResearchCompletedParkinson's DiseaseUnited States
-
Boston Scientific CorporationCompletedParkinson's DiseaseUnited States
-
Xuanwu Hospital, BeijingNot yet recruiting
-
Paul LarsonCompleted
-
Stanford UniversityCompletedParkinson's DiseaseUnited States
-
University Hospital, MontpellierCompletedObsessive-compulsive Disorder (OCD)France
-
Ali Rezai, MDCompleted
-
A.O. Ospedale Papa Giovanni XXIIIAssociazione Italiana Parkinsoniani (AIP)- Sezione BergamoUnknownParkinson's Disease | Deep Brain Stimulation | DBS | STNItaly