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ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.
ADHD children (ages 12-17 years) will be recruited. Cognitive testing and basic anatomic brain MRI will be performed during visit 1. During visit 2, baseline TMS-based physiologic measures will be obtained. Children will also complete a behavioral task (stop signal task) while electroencephalography (EEG) data is collected. After these baseline measures, two trains of Intermittent Theta Burst Stimulation (iTBS) will be delivered. (Intermittent Theta Burst Stimulation is a form of repetitive TMS.) The first train of iTBS will be randomized to sham vs. active in a 1:1 ratio. The second train of iTBS is active for all participants. After both iTBS trains are completed, repeat TMS-based measures, stop signal task and EEG data will be collected again. Visit 3 will be one week after visit 2. Visit 3 is a virtual computer-based visit to assess for any potential side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active repetitive TMS | Active Comparator |
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| Sham repetitive TMS | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active repetitive TMS | Device | In this study, ADHD children will receive two trains of intermittent theta burst stimulation. Intermittent theta burst stimulation is a form of repetitive TMS. Both iTBS trains will be active stimulation using the active TMS coil. |
| Measure | Description | Time Frame |
|---|---|---|
| TMS-based Short-Interval Intracortical Inhibition (SICI) | This is a measure of primary motor cortex inhibitory activity. | Immediately after each iTBS train |
| EEG-based beta activity | This is a measure of beta-band activity during performance of stop signal task. | Immediately after each iTBS train |
| TMS-based Cortical Silent Period (cSP) | This is a measure of primary motor cortex inhibitory activity. | Immediately after each iTBS train |
| EEG-based alpha activity | This is a measure of alpha-band activity during performance of stop signal task. | Immediately after each iTBS train |
| Measure | Description | Time Frame |
|---|---|---|
| Stop Signal Reaction Time | This is a measure calculated from the stop signal task. This is an experimental measure of how well the participant can inhibit a motor action. | Immediately after each iTBS train |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karlee Migneault, B.A. | Contact | 513-803-5299 | Karlee.Migneault@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Steve W Wu, M.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Sham repetitive TMS | Device | In this study, ADHD children will receive two trains of intermittent theta burst stimulation. Intermittent theta burst stimulation is a form of repetitive TMS. The first iTBS train will be sham stimulation using the sham TMS coil. The second iTBS train will be active stimulation using the active TMS coil. |
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