Tourette Syndrome in AdolescenceNCT05558566
Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
A study testing Neurofeedback from the SMA in people with Tourette Syndrome in Adolescence, run by Yale University at 1 site in United States.
Trial summary
This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Tourette Syndrome in Adolescence
- What is being tested?
- Neurofeedback from the SMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 20 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls, 10 to 16 years of age
- A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD), with active tics that can be executed without head movement, and a YGTSS score of at least 13 (for TS participants) or at least 12 (for CTD participants)
- Currently stable medication treatment and no planned changes in medication for the duration of the study.
- Family residence within 2 hours of Yale Medical Center with ability and willingness to attend assessment and fMRI visits.
- Children and their parents are expected to be able to speak and understand spoken English in order to participate in a clinical assessment of TS and related psychopathology.
- Subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, and will have 3) a body weight of less than 250 lbs. and 4) no claustrophobia.
Who cannot join
- Intelligence quotient below 80
- Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder or current suicidality
- Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder
- Recently initiated psychotherapy. Participation in the study will not be allowed within 8 weeks of the initiation of psychotherapy. Ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, but parents will be asked not to initiate any new psychotherapy for the child during the study
- Subjects may also be excluded after the first MR scan if we are unable to localize the two regions in their brain that are used as targets for the active and control neurofeedback conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06520
Michelle Hampson, PhD
About this study
This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).
Read the detailed description
The training portion of this study involves three fMRI NF sessions, with six NF scans per session. NF scans alternate between up-regulate and down-regulate blocks in which participants are cued to increase or decrease activity in the target region while receiving feedback on activity in the region at the bottom of the screen in the form of a line graph. The experimental group receives feedback from the supplementary motor area (SMA) and the control group receives feedback from a control region of the brain.
- Conditions
- Tourette Syndrome in Adolescence
- Being tested
- Neurofeedback from the SMA, Neurofeedback from control region
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback from the SMAOther
Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal
Neurofeedback from control regionOther
Feedback is provided regarding activity in a control region and participant attempts to control activity in that region using the feedback as a training signal.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback from the SMA | Experimental | Not described Receives: Other: Neurofeedback from the SMA |
| Neurofeedback from control region | Active comparator | Not described Receives: Other: Neurofeedback from control region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms after the intervention compared to baseline
Symptom severity is assessed using the Yale Global Tic Severity Scale (YGTSS) before NF and at several time points in the month following the completion of NF training.
Measured: Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF
Secondary outcomes (1)
Change in control over activity in the SMA target region during NF compared to baseline
Control over the SMA is computed as the difference in the blood-oxygenation-level-dependent (BOLD) signal in SMA during up-regulate compared to down-regulate blocks. This measure is computed both in the NF scans and in the control task scans prior to the start of NF. Improvement in control for each subject is the difference of these two (i.e., control during NF minus control during pre-intervention control task scans).
Measured: Baseline and during NF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Nov 2022
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette Syndrome in AdolescenceStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
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, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558566
- Sponsor's protocol ID
- 2000033043
- Other IDs
- 1R01MH127147-01A1
- Status last verified
- Jun 2026
- First submitted
- 21 Sep 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded to the National Institute of Mental Health Data Archive (NDA) and made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
- ClinicalTrials.gov ID
- NCT05558566
- Acronym / sponsor ID
- 2000033043
- Conditions
- Tourette Syndrome in Adolescence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 28 Sep 2022 (actual)
- 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.
This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).
Detailed description
The training portion of this study involves three fMRI NF sessions, with six NF scans per session. NF scans alternate between up-regulate and down-regulate blocks in which participants are cued to increase or decrease activity in the target region while receiving feedback on activity in the region at the bottom of the screen in the form of a line graph. The experimental group receives feedback from the supplementary motor area (SMA) and the control group receives feedback from a control region of the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback from the SMA | Experimental | Other: Neurofeedback from the SMA |
| Neurofeedback from control region | Active comparator | Other: Neurofeedback from control region |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Boys and girls, 10 to 16 years of age
- A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD), with active tics that can be executed without head movement, and a YGTSS score of at least 13 (for TS participants) or at least 12 (for CTD participants)
- Currently stable medication treatment and no planned changes in medication for the duration of the study.
- Family residence within 2 hours of Yale Medical Center with ability and willingness to attend assessment and fMRI visits.
- Children and their parents are expected to be able to speak and understand spoken English in order to participate in a clinical assessment of TS and related psychopathology.
Key exclusion criteria (5 listed)
- Intelligence quotient below 80
- Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder or current suicidality
- Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder
- Recently initiated psychotherapy. Participation in the study will not be allowed within 8 weeks of the initiation of psychotherapy. Ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, but parents will be asked not to initiate any new psychotherapy for the child during the study
- Subjects may also be excluded after the first MR scan if we are unable to localize the two regions in their brain that are used as targets for the active and control neurofeedback conditions.
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 |
|---|---|---|
| Neurofeedback from the SMAFeedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal | Other | Neurofeedback from the SMA |
| Neurofeedback from control regionFeedback is provided regarding activity in a control region and participant attempts to control activity in that region using the feedback as a training signal. | Other | Neurofeedback from control region |
Primary outcome
Change in symptoms after the intervention compared to baseline
Time frame: Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF
Symptom severity is assessed using the Yale Global Tic Severity Scale (YGTSS) before NF and at several time points in the month following the completion of NF training.
1 secondary outcome
Change in control over activity in the SMA target region during NF compared to baseline
Time frame: Baseline and during NF
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. Data will be uploaded to the National Institute of Mental Health Data Archive (NDA) and made available to other researchers.
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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.
Michelle Hampson, PhD 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 from the SMA in people with Tourette Syndrome in Adolescence, 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheyenne Harris-Starling (203-737-6055, cheyenne.harris-starling@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms after the intervention compared to baseline (time frame: Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF). 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 9 Jun 2026.