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NCT Number: NCT06325813

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.

Recruiting

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Karlee Migneault

CONTACT

[email protected]

513-803-5299

Steve Wu, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ADHD diagnosis
  • Ages 12-17 years
  • Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit

Exclusion criteria

  • 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
  • Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)
  • For biological females who are post-menarche, current pregnancy based on urine pregnancy test.
  • Baseline problem of hearing impairment or chronic tinnitus
  • Any clinically significant finding on brain MRI
  • History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder
  • Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)
  • Neuroleptic/antipsychotic medication(s)
  • Inability to undergo MRI
  • Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician
  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. TMS-based Short-Interval Intracortical Inhibition (SICI)

    Time frame: Immediately after each iTBS train

    This is a measure of primary motor cortex inhibitory activity.

  2. EEG-based beta activity

    Time frame: Immediately after each iTBS train

    This is a measure of beta-band activity during performance of stop signal task.

  3. TMS-based Cortical Silent Period (cSP)

    Time frame: Immediately after each iTBS train

    This is a measure of primary motor cortex inhibitory activity.

  4. EEG-based alpha activity

    Time frame: Immediately after each iTBS train

    This is a measure of alpha-band activity during performance of stop signal task.

Secondary outcomes

  1. Stop Signal Reaction Time

    Time frame: Immediately after each iTBS train

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karlee Migneault, B.A.

CONTACT

[email protected]

513-803-5299

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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