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Thalamic Deep Brain Stimulation for Tourette Syndrome

Primary Purpose

Tourette Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalamic deep brain stimulation
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette Syndrome, Deep Brain Stimulation, Video assessment, YGTSS, TSSL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of Cleveland

Outcomes

Primary Outcome Measures

modified Rush Video Rating Scale (mRVRS)

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

Full Information

First Posted
April 5, 2006
Last Updated
May 6, 2022
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00311909
Brief Title
Thalamic Deep Brain Stimulation for Tourette Syndrome
Official Title
Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Medtronic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Tourette Syndrome, Deep Brain Stimulation, Video assessment, YGTSS, TSSL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Thalamic deep brain stimulation
Primary Outcome Measure Information:
Title
modified Rush Video Rating Scale (mRVRS)
Secondary Outcome Measure Information:
Title
tic counts (on video recording)
Title
Yale Global Tourette Severity Scale (YGTSS)
Title
Tourette Syndrome Symptom List (TSSL)
Title
Quality of Life Visual Analog Scale (VAS)
Title
SF-36
Title
Neuropsychological battery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Maciunas, MD MPH FACS
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Thalamic Deep Brain Stimulation for Tourette Syndrome

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