NCT00311909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

April 5, 2006

Last Update Submit

May 6, 2022

Conditions

Tourette Syndrome

Keywords

Tourette SyndromeDeep Brain StimulationVideo assessmentYGTSSTSSL

Outcome Measures

Primary Outcomes (1)

  • modified Rush Video Rating Scale (mRVRS)

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Thalamic deep brain stimulationDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental Disorders

Study Officials

  • Robert J Maciunas, MD MPH FACS

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2006

First Posted

April 6, 2006

Study Start

June 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

US(1)