Neurofeedback for Tourette Syndrome

Not Applicable

Completed

• Conditions: Tourette Syndrome; Chronic Tic Disorder
• Interventions: Procedure: Neurofeedback; Procedure: Sham feedback

• Registration Number: NCT01702077
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham first	Neurofeedback	Sham feedback then neurofeedback
Sham first	Sham feedback	Sham feedback then neurofeedback
Neurofeedback first	Neurofeedback	Neurofeedback then sham feedback
Neurofeedback first	Sham feedback	Neurofeedback then sham feedback

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States