Neurofeedback for Tourette Syndrome

This study is currently recruiting participants.
Verified August 2013 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01702077
First received: October 3, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Tourette Syndrome
Chronic Tic Disorder
Procedure: Neurofeedback
Procedure: Sham feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurofeedback first
Neurofeedback then sham feedback
Procedure: Neurofeedback
Other Names:
  • biofeedback
  • real-time fMRI biofeedback
Procedure: Sham feedback
Experimental: Sham first
Sham feedback then neurofeedback
Procedure: Neurofeedback
Other Names:
  • biofeedback
  • real-time fMRI biofeedback
Procedure: Sham feedback

  Eligibility

Ages Eligible for Study:   11 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702077

Contacts
Contact: Christopher Walsh, MS 203-737-6055 christopher.walsh@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Michelle Hampson, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01702077     History of Changes
Other Study ID Numbers: 0206017435, R01MH095789
Study First Received: October 3, 2012
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
neurofeedback
biofeedback
real-time fMRI
rt-fMRI
functional connectivity
fMRI

Additional relevant MeSH terms:
Tourette Syndrome
Tic Disorders
Tics
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 17, 2014