Thalamic Deep Brain Stimulation for Tourette Syndrome

Phase 2

Completed

• Conditions: Tourette Syndrome

• Registration Number: NCT00311909
• Lead Sponsor: University Hospitals Cleveland Medical Center

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 available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-06
• Last Update Posted: 2022-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
modified Rush Video Rating Scale (mRVRS)

Secondary Outcome Measures

Name	Time	Method
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)
SF-36

Trial Locations

Locations (1)

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States