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Clinical Trials/NCT00311909
NCT00311909
Completed
Phase 2

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

University Hospitals Cleveland Medical Center1 site in 1 country5 target enrollmentJune 2005
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ConditionsTourette Syndrome

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
University Hospitals Cleveland Medical Center
Enrollment
5
Locations
1
Primary Endpoint
modified Rush Video Rating Scale (mRVRS)
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
April 2006
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

modified Rush Video Rating Scale (mRVRS)

Secondary Outcomes

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

Study Sites (1)

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