Neurofeedback for Tourette Syndrome (NCT01702077) | Clinical Trial Compass
CompletedNot Applicable
Neurofeedback for Tourette Syndrome
United States21 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range
11 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tic severity
Timeframe: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.
2
Tic severity
Timeframe: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.