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Thalamic Deep Brain Stimulation for Tourette Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311909
First Posted: April 6, 2006
Last Update Posted: April 6, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by:
University Hospitals Cleveland Medical Center
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial

Resource links provided by NLM:


Further study details as provided by University Hospitals Cleveland Medical Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311909


Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Medtronic
Investigators
Principal Investigator: Robert J Maciunas, MD MPH FACS University Hospitals Cleveland Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00311909     History of Changes
Other Study ID Numbers: UHC DBS TS
First Submitted: April 5, 2006
First Posted: April 6, 2006
Last Update Posted: April 6, 2006
Last Verified: April 2006

Keywords provided by University Hospitals Cleveland Medical Center:
Tourette Syndrome
Deep Brain Stimulation
Video assessment
YGTSS
TSSL

Additional relevant MeSH terms:
Tourette Syndrome
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders