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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

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

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

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

Additional relevant MeSH terms:
Brain Diseases
Tourette Syndrome
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013