Trial record 2 of 9 for:    tourette's fMRI

Neurofeedback for Tourette Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01702077
First received: October 3, 2012
Last updated: June 13, 2014
Last verified: June 2014

October 3, 2012
June 13, 2014
October 2012
June 2017   (final data collection date for primary outcome measure)
  • Tic severity [ Time Frame: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback. ] [ Designated as safety issue: No ]
    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.
  • Tic severity [ Time Frame: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback. ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01702077 on ClinicalTrials.gov Archive Site
  • Control over target brain area [ Time Frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]
    Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
  • Control over target brain area [ Time Frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]
    Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
Same as current
  • Functional connectivity patterns in the brain [ Time Frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]
    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
  • Functional connectivity patterns in the brain [ Time Frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]
    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
  • Clinical improvement [ Time Frame: Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback ] [ Designated as safety issue: No ]
    The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback
  • Functional connectivity patterns in the brain [ Time Frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]
    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
  • Functional connectivity patterns in the brain [ Time Frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]
    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
 
Neurofeedback for Tourette Syndrome
Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Tourette Syndrome
  • Chronic Tic Disorder
  • Procedure: Neurofeedback
    Other Names:
    • biofeedback
    • real-time fMRI biofeedback
  • Procedure: Sham feedback
  • Experimental: Neurofeedback first
    Neurofeedback then sham feedback
    Interventions:
    • Procedure: Neurofeedback
    • Procedure: Sham feedback
  • Experimental: Sham first
    Sham feedback then neurofeedback
    Interventions:
    • Procedure: Neurofeedback
    • Procedure: Sham feedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2017
June 2017   (final data collection date for primary outcome measure)

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
  • Inability to keep head still in mock scanner
  • Inability or unwillingness to understand or follow the instructions
  • Pregnancy or possible pregnancy
  • Subjects may also be excluded after the first magnetic resonance scan if we are unable to localize a region of their supplementary motor area involved in tics - leaving us without a target area for biofeedback.
Both
11 Years to 19 Years
No
Contact: Christopher Walsh, MS 203-737-6055 christopher.walsh@yale.edu
United States
 
NCT01702077
0206017435, R01MH095789
No
Yale University
Yale University
National Institute of Mental Health (NIMH)
Principal Investigator: Michelle Hampson, Ph.D. Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP