An interventional study of Neurofeedback and Sham feedback in Tourette Syndrome and Chronic Tic Disorder, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 11 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-08-27.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.
This study's enrollment of 21 is below the median of 34 across 166 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Neurofeedback then sham feedback
Procedure: Neurofeedback · Procedure: Sham feedback
Sham feedback then neurofeedback
Procedure: Neurofeedback · Procedure: Sham feedback
Also known as: biofeedback, real-time fMRI biofeedback
Tic severity
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.
Time frame: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.
Tic severity
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.
Time frame: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.
Control over target brain area
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.
Time frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Control over target brain area
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.
Time frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Functional connectivity patterns in the brain
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Time frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Functional connectivity patterns in the brain
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Time frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Clinical improvement
The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback
Time frame: Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Yale University