Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325813
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-16
Brief Title:
ADHD PreSMA Response Inhibition Therapy
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
ADHD PreSMA Response Inhibition Therapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None