Thalamic Deep Brain Stimulation for Tourette Syndrome

This study has been completed.

Sponsor:

Collaborator:

Medtronic

Information provided by:

University Hospitals of Cleveland

ClinicalTrials.gov Identifier:

NCT00311909

First received: April 5, 2006

Last updated: NA

Last verified: April 2006

History: No changes posted

Tracking Information

First Received Date ^ICMJE

April 5, 2006

Last Updated Date

April 5, 2006

Start Date ^ICMJE

June 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Thalamic Deep Brain Stimulation for Tourette Syndrome

Official Title ^ICMJE

Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Tourette Syndrome

Intervention ^ICMJE

Device: Thalamic deep brain stimulation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00311909

Other Study ID Numbers ^ICMJE

UHC DBS TS

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospitals of Cleveland

Collaborators ^ICMJE

Medtronic

Investigators ^ICMJE

Principal Investigator:

Robert J Maciunas, MD MPH FACS

University Hospitals of Cleveland

Information Provided By

University Hospitals of Cleveland

Verification Date

April 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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