Neurofeedback for Tourette Syndrome

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT01702077

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tourette Syndrome Chronic Tic Disorder	Procedure: Neurofeedback Procedure: Sham feedback	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Tic severity [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 [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 Outcome Measures

Control over target brain area [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.
Control over target brain area [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.

Other Outcome Measures

Functional connectivity patterns in the brain [Assessed approximately half a week BEFORE biofeedback/sham biofeedback.]
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Functional connectivity patterns in the brain [Assessed approximately half a week AFTER biofeedback/sham biofeedback.]
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Clinical improvement [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.