Neurofeedback for Tourette Syndrome

August 24, 2018 updated by: Yale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tic severity
Time Frame: Tic severity assessed approximately half a week PRIOR TO beginning 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.
Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.
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.
Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Control over target brain area
Time Frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
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.
Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Control over target brain area
Time Frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
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.
Assessed approximately half a week AFTER biofeedback/sham biofeedback.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional connectivity patterns in the brain
Time Frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Functional connectivity patterns in the brain
Time Frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Clinical improvement
Time Frame: Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback
The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback
Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michelle Hampson, Ph.D., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0206017435
  • R01MH095789 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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