Tourette SyndromeNCT01702077
Neurofeedback for Tourette Syndrome
A study testing Neurofeedback in people with Tourette Syndrome and Chronic Tic Disorder, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Tourette Syndrome, Chronic Tic Disorder
- What is being tested?
- Neurofeedback
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome
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.
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Being tested
- Neurofeedback, Sham feedback
- Keywords
- neurofeedback, biofeedback, real-time fMRI, rt-fMRI, functional connectivity, fMRI
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackProcedure or surgery
Also called biofeedback, real-time fMRI biofeedback
Sham feedbackProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback first | Experimental | Neurofeedback then sham feedback Receives: Procedure: Neurofeedback; Procedure: Sham feedback |
| Sham first | Experimental | Sham feedback then neurofeedback Receives: Procedure: Neurofeedback; Procedure: Sham feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michelle Hampson, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702077
- Sponsor's protocol ID
- 0206017435
- Other IDs
- R01MH095789
- Status last verified
- Aug 2018
- First submitted
- 3 Oct 2012
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome
- ClinicalTrials.gov ID
- NCT01702077
- Acronym / sponsor ID
- 0206017435
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Keywords
- neurofeedback, biofeedback, real-time fMRI, rt-fMRI, functional connectivity, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback first | Experimental | Procedure: Neurofeedback, Procedure: Sham feedbackNeurofeedback then sham feedback |
| Sham first | Experimental | Procedure: Neurofeedback, Procedure: Sham feedbackSham feedback then neurofeedback |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackAlso: biofeedback, real-time fMRI biofeedback | Procedure or surgery | Neurofeedback first, Sham first |
| Sham feedback | Procedure or surgery | Neurofeedback first, Sham first |
Primary outcome
Tic severity
Time frame: Tic severity assessed approximately half a week PRIOR TO beginning 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.
Tic severity
Time frame: 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.
2 secondary outcomes
Control over target brain area
Time frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Control over target brain area
Time frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
Related trials for Tourette Syndrome
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Deep Brain Stimulation Therapy in Movement Disorders
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Hampson, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Tourette Syndrome and Chronic Tic Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tic severity (time frame: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.