Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
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|ClinicalTrials.gov Identifier: NCT05558566|
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : November 23, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Tourette Syndrome in Adolescence||Other: Neurofeedback from the SMA Other: Neurofeedback from control region||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Neurofeedback From the Supplementary Motor Area for Tourette Syndrome|
|Actual Study Start Date :||November 1, 2022|
|Estimated Primary Completion Date :||December 20, 2026|
|Estimated Study Completion Date :||January 20, 2027|
|Experimental: Neurofeedback from the SMA||
Other: Neurofeedback from the SMA
Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal
|Active Comparator: Neurofeedback from control region||
Other: Neurofeedback from control region
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.
- 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.
- Change in control over activity in the SMA target region during NF compared to baseline [ Time Frame: Baseline and during NF ]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).
- Changes in resting state functional connectivity to SMA in NF group [ Time Frame: Baseline and one month post-NF ]Functional connectivity is measured as temporal synchrony in the BOLD data in functional scans in which participants are just resting in the scanner. These scans are collected at baseline and one month after the neurofeedback training. Connectivity to the SMA will be computed for each time point and the change in the neurofeedback group will be examined and correlated with symptom improvement.
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|Ages Eligible for Study:||10 Years to 16 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Boys and girls, 10 to 16 years of age
- A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder, with active tics that can be executed without head movement, and a YGTSS score of at least 13
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558566
|Contact: Cheyenne Harris-Starlingfirstname.lastname@example.org|
|Contact: Jitendra Awastiemail@example.com|
|United States, Connecticut|
|Yale University School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator: Michelle Hampson, PhD|
|Principal Investigator:||Michelle Hampson, PhD||Yale University|
|Responsible Party:||Yale University|
|Other Study ID Numbers:||
1R01MH127147-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||September 28, 2022 Key Record Dates|
|Last Update Posted:||November 23, 2022|
|Last Verified:||November 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Data will be uploaded to the National Institute of Mental Health Data Archive (NDA) and made available to other researchers.|
|Time Frame:||Data are uploaded every 6 months to NDA during the trial. Demographic and baseline data are released by NDA four months after upload. Outcome measures are released by NDA upon publication.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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