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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH127147-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback from the SMA | Experimental |
| |
| Neurofeedback from control region | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback from the SMA | Other | Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheyenne Harris-Starling | Contact | 203-737-6055 | cheyenne.harris-starling@yale.edu | |
| Jitendra Awasti | Contact | 203-737-6055 | jitendra.awasti@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Hampson, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06520 | United States |
Data will be uploaded to the National Institute of Mental Health Data Archive (NDA) and made available to other researchers.
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.
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| Neurofeedback from control region | Other | 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. |
|
| Baseline and during NF |
| Baseline and one month post-NF |