ADHD PreSMA Response Inhibition Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: Active repetitive TMS; Device: Sham repetitive TMS

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karlee Migneault, B.A.; Phone Number: 513-803-5299; Email: Karlee.Migneault@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Karlee Migneault; Phone Number: 513-803-5299; Email: karlee.migneault@cchmc.org
      • Principal Investigator: Steve Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active repetitive TMS	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 Comparator: Sham repetitive TMS	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Steve W Wu, M.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 16, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ADHD; Transcranial Magnetic Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: CIN001 - ADHD PreSMART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes