NCT06325813

ADHD PreSMA Response Inhibition Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DEVICE	Active repetitive TMS	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.
DEVICE	Sham repetitive TMS	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.

Timeline

• Start date: 2024-09-03
• Primary completion: 2027-05-31
• Completion: 2027-12-31
• First posted: 2024-03-22
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study