Brief Title
Thalamic Deep Brain Stimulation for Tourette Syndrome
Official Title
Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
modified Rush Video Rating Scale (mRVRS)
Secondary Outcome
tic counts (on video recording)
Condition
Tourette Syndrome
Intervention
Thalamic deep brain stimulation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
5
Start Date
June 2005
Completion Date
April 2006
Primary Completion Date
April 2006
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Robert J Maciunas, MD MPH FACS, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00311909
Organization ID
UHC DBS TS
Responsible Party
Sponsor
Study Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Medtronic
Study Sponsor
Robert J Maciunas, MD MPH FACS, Principal Investigator, University Hospitals Cleveland Medical Center
Verification Date
May 2022