NCT06325813 · Children's Hospital Medical Center, Cincinnati
ADHD PreSMA Response Inhibition Therapy
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
TMS-based Short-Interval Intracortical Inhibition (SICI)
Time frame: Immediately after each iTBS train
This is a measure of primary motor cortex inhibitory activity.
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.
TMS-based Cortical Silent Period (cSP)
Time frame: Immediately after each iTBS train
This is a measure of primary motor cortex inhibitory activity.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2026 · Source of record for eligibility and locations