Skip to main content
Clinical Trials/NCT01702077
NCT01702077
Completed
Not Applicable

Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome

Yale University1 site in 1 country21 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
Yale University
Enrollment
21
Locations
1
Primary Endpoint
Tic severity
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to train patients with tic disorders to control activity in a region of their brain that has been associated with the urge to tic. Patients will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. In separate sessions, patients will be given sham feedback based on the brain patterns of a prior subject rather than their own brain patterns. Our primary hypothesis is that the biofeedback training will reduce their tic symptoms more than the sham feedback.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
December 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of Tourette Syndrome or Chronic Tic Disorder
  • currently active tics
  • aged 11-19
  • ability to execute most common tics without moving head while lying on back

Exclusion Criteria

  • Blindness (because feedback is provided visually)
  • Lifetime diagnosis of pervasive developmental disorder, bipolar disorder, or psychotic disorder.
  • Presence of any serious psychiatric or psychosocial condition requiring initiation of new treatment or change in current treatment.
  • Neurological conditions affecting central nervous system, with the exception that predisposition to migraine will not be grounds for exclusion
  • Change in medication in the month prior to beginning the study
  • Unwillingness to keep medication stable over the course of the intervention
  • Full braces (but some retainers are OK)
  • Claustrophobia of a degree that they cannot comfortably be scanned
  • If common tics involve dramatic changes in breathing that could alter blood oxygenation measurements
  • Inability to keep head still while executing most common tics

Outcomes

Primary Outcomes

Tic severity

Time Frame: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.

A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.

Secondary Outcomes

  • Control over target brain area(Assessed approximately half a week AFTER biofeedback/sham biofeedback.)

Study Sites (1)

Loading locations...

Similar Trials