Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Location status: Recruiting
Location contact
Michelle Hampson, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05558566
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).
Interested in participating?
Request Info10 year–16 year
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
Location status: Recruiting
Michelle Hampson, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal
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.
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.
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).
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.
Contact information is provided by the study sponsor or research team.
Cheyenne Harris-Starling
CONTACT
Jitendra Awasti
CONTACT
Yale University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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