Thalamic Deep Brain Stimulation for Tourette Syndrome | NCT00311909

Studies
Thalamic Deep Brain Stimulation for Tourette Syndrome

NCT00311909

Sponsor

University Hospitals Cleveland Medical Center

Status

Completed

Last Update Posted

May 12, 2022Actual

Enrollment

5Actual

Phase

Phase 2

Conditions

Tourette Syndrome

Interventions

Thalamic deep brain stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Apr 2006Actual

Completion Date

Apr 2006Actual

First Submitted Date

Apr 5, 2006

First Submission Date that Met QC Criteria

Apr 5, 2006

First Posted Date

Apr 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2022

Last Update Posted Date

May 12, 2022Actual

Name	Class
Medtronic	INDUSTRY

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Name	Type	Description	Arm Group Labels	Other Names
Thalamic deep brain stimulation	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
modified Rush Video Rating Scale (mRVRS)

Secondary Outcomes

Measure	Description	Time Frame
tic counts (on video recording)
Yale Global Tourette Severity Scale (YGTSS)
Tourette Syndrome Symptom List (TSSL)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J Maciunas, MD MPH FACS	University Hospitals Cleveland Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Cleveland		Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D005879	Tourette Syndrome

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided