CClinicalTrials.gg
Sign In
CompletedNCT00311909Updated May 12, 2022

Thalamic Deep Brain Stimulation for Tourette Syndrome

A Phase 2 interventional study of Thalamic deep brain stimulation in Tourette Syndrome, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-12.

Sponsored by University Hospitals Cleveland Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tourette Syndrome

Keywords

  • Tourette Syndrome
  • Deep Brain Stimulation
  • Video assessment
  • YGTSS
  • TSSL
03

In context

Tourette Syndrome

220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.

This study's enrollment of 5 is below the median of 34 across 166 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
5 participants (actual)

Interventions

  • DeviceThalamic deep brain stimulation
06

What researchers measure

Primary outcomes

  1. modified Rush Video Rating Scale (mRVRS)

Secondary outcomes

  1. tic counts (on video recording)

  2. Yale Global Tourette Severity Scale (YGTSS)

  3. Tourette Syndrome Symptom List (TSSL)

  4. Quality of Life Visual Analog Scale (VAS)

  5. SF-36

  6. Neuropsychological battery

07

Study locations

1 site
  • University Hospitals of Cleveland
    Cleveland, Ohio 44106, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00311909
Lead sponsor
University Hospitals Cleveland Medical Center
Collaborators
Medtronic
Responsible party
Sponsor
First posted
Apr 6, 2006
Start date
Jun 2005
Primary completion
Apr 2006
Completion
Apr 2006
Last update
May 12, 2022

Study contacts

Robert J Maciunas, MD MPH FACS
principal investigator · University Hospitals Cleveland Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Tourette Syndrome→

Other studies from this sponsor

University Hospitals Cleveland Medical Center

Start the discussion