Clinical trial NCT01702077: Neurofeedback for Tourette Syndrome
Official title: Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Chronic Tic Disorder
Keywords: neurofeedback
biofeedback
real-time fMRI
rt-fMRI
functional connectivity
fMRI
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-10-05
Enrollment: 21
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tic severity
timeFrame: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.
measure: Tic severity
timeFrame: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.
Secondary outcomes:
measure: Control over target brain area
timeFrame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
measure: Control over target brain area
timeFrame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Other outcomes:
measure: Functional connectivity patterns in the brain
timeFrame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
measure: Functional connectivity patterns in the brain
timeFrame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
measure: Clinical improvement
timeFrame: Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Michelle Hampson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: