Thalamic Deep Brain Stimulation for Tourette Syndrome

NCT ID: NCT00311909

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-04-30

Brief Summary

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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

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Conditions

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Tourette Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Thalamic deep brain stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert J Maciunas, MD MPH FACS

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UHC DBS TS

Identifier Type: -

Identifier Source: org_study_id

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