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NCT00311909 Clinical Trial

Thalamic Deep Brain Stimulation for Tourette Syndrome

Tourette Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311909
Other study ID # UHC DBS TS
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 2005
Est. completion date April 2006

Study information
Verified date May 2022
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Thalamic deep brain stimulation

Locations
Country Name City State
United States University Hospitals of Cleveland Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center Medtronic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary modified Rush Video Rating Scale (mRVRS)
Secondary tic counts (on video recording)
Secondary Yale Global Tourette Severity Scale (YGTSS)
Secondary Tourette Syndrome Symptom List (TSSL)
Secondary Quality of Life Visual Analog Scale (VAS)
Secondary SF-36
Secondary Neuropsychological battery
See also
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Completed NCT02900144 - Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) N/A
Completed NCT02216474 - Brain Stimulation in Movement Disorders N/A
Completed NCT02256475 - Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Phase 1
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Completed NCT00231985 - Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Phase 2
Completed NCT00206336 - An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Phase 3
Terminated NCT03732534 - Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome Phase 2