Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
ConditionTourette Syndrome in Adolescence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-16
SponsorYale University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neurofeedback from the SMA
Other interventionFeedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal
Neurofeedback from control region
Other interventionFeedback is provided regarding activity in a control region and participant attempts to control activity in that region using the feedback as a training signal.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Neurofeedback from the SMAExperimental treatment 1 intervention
Group B: Neurofeedback from control regionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NFSecondary 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).
Time frame
Baseline and during NFOther outcomes
1
Changes in resting state functional connectivity to SMA in NF group
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.
Time frame
Baseline and one month post-NFSponsors and contacts
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Yale University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov