Neurofeedback for Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702077
• Other study ID #: 0206017435
• Secondary ID: R01MH095789
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Tic Disorder
• Syndrome
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Procedure:
• Neurofeedback

• Sham feedback

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional connectivity patterns in the brain	Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.	Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Other	Functional connectivity patterns in the brain	Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.	Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Other	Clinical improvement	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
Primary	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.	Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.
Primary	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.	Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.
Secondary	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.	Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Secondary	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.	Assessed approximately half a week AFTER biofeedback/sham biofeedback.