Thalamic Deep Brain Stimulation for Tourette Syndrome

This study has been completed.

First Received: April 5, 2006 No Changes Posted

Sponsors and Collaborators:	University Hospitals of Cleveland Medtronic
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00311909

Purpose

The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.

Condition	Intervention	Phase
Tourette Syndrome	Device: Thalamic deep brain stimulation	Phase II

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Tourette syndrome

MedlinePlus related topics: Tourette Syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial

Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:

modified Rush Video Rating Scale (mRVRS)
at defined points including baseline and 3 months

Secondary Outcome Measures:

tic counts (on video recording)
Yale Global Tourette Severity Scale (YGTSS)
Tourette Syndrome Symptom List (TSSL)
Quality of Life Visual Analog Scale (VAS)
SF-36
Neuropsychological battery

Estimated Enrollment:	5
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 18 or older
Diagnosis of Tourette Syndrome by DSM-IV
Tic frequency at least one per minute at screening
prior failure of at least two dopamine receptor or presynaptic blockers
negative impact on quality of life

Exclusion Criteria:

significant structural brain lesion (on imaging studies)
significant dementia
severe head trauma preceding onset of tics
use of dopamine receptor blockers prior to recognition of tics
prior implanted electrical device
electroconvulsive therapy (ECT) within 24 months
suicide attempt within 12 months
significant sociopathic personality
current or planned pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311909

Locations

United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals of Cleveland

Medtronic

Investigators

Principal Investigator:

Robert J Maciunas, MD MPH FACS

University Hospitals of Cleveland

More Information

No publications provided

Study ID Numbers:	UHC DBS TS
Study First Received:	April 5, 2006
Last Updated:	April 5, 2006
ClinicalTrials.gov Identifier:	NCT00311909 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University Hospitals of Cleveland:

Tourette Syndrome
Deep Brain Stimulation
Video assessment
YGTSS
TSSL

Study placed in the following topic categories:

Ganglion Cysts
Basal Ganglia Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Brain Diseases
Neurodegenerative Diseases

Tics
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Movement Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood

Additional relevant MeSH terms:

Disease
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Tourette Syndrome
Tic Disorders
Brain Diseases
Neurodegenerative Diseases

Pathologic Processes
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Syndrome
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on May 07, 2009