ADHD PreSMA Response Inhibition Therapy

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

ADHD PreSMA Response Inhibition Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325813
• Other study ID #: CIN001 - ADHD PreSMART
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Karlee Migneault, B.A.
• Phone: 513-803-5299
• Email: Karlee.Migneault[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

1. ADHD diagnosis

2. Ages 12-17 years

3. Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit

Exclusion Criteria:

1. Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition

2. Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)

3. For biological females who are post-menarche, current pregnancy based on urine pregnancy test.

4. Baseline problem of hearing impairment or chronic tinnitus

5. Any clinically significant finding on brain MRI

6. History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder

7. Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)

8. Neuroleptic/antipsychotic medication(s)

9. Inability to undergo MRI

10. Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician

11. Substance abuse or dependence within the past year, based on 1) separate screening process of asking parent/guardian and participant, and 2) positive urine drug screen. Exception will be made for positive urine drug screen due to prescribed ADHD medication

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMS-based Short-Interval Intracortical Inhibition (SICI)	This is a measure of primary motor cortex inhibitory activity.	Immediately after each iTBS train
Primary	EEG-based beta activity	This is a measure of beta-band activity during performance of stop signal task.	Immediately after each iTBS train
Primary	TMS-based Cortical Silent Period (cSP)	This is a measure of primary motor cortex inhibitory activity.	Immediately after each iTBS train
Primary	EEG-based alpha activity	This is a measure of alpha-band activity during performance of stop signal task.	Immediately after each iTBS train
Secondary	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