Actively Recruiting
ADHD PreSMA Response Inhibition Therapy
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-27
40
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Children aged 12 to 17 with Attention Deficit Hyperactivity Disorder (ADHD) are being studied to understand how brain stimulation affects their ability to control impulses. Researchers focus on a brain region called the pre-supplementary motor area (pre-SMA), which is known to function abnormally in ADHD. This study evaluates the effects of stimulating this brain area using a technique called Transcranial Magnetic Stimulation (TMS) to see how it influences measures linked to inhibitory control. Participants will undergo cognitive testing and brain MRI during the first visit. The second visit includes baseline physiological measures using TMS, and a behavioral task called the stop signal task while brain activity is recorded using EEG. After this, participants receive two rounds of intermittent theta burst stimulation (iTBS), a special type of repetitive TMS. The first round is randomized to either actual stimulation or a sham (placebo) version, while the second round is always active stimulation. Following the stimulation, the same tests and measurements are repeated. A third visit, conducted virtually one week later, checks for any side effects. During the study, children complete brain scans, cognitive tests, EEG recordings, and TMS assessments to monitor brain activity and responses to stimulation. Researchers measure specific brain signals and reaction times immediately after each stimulation session to evaluate changes. Safety is monitored during the follow-up virtual visit. The entire process spans at least one week after the stimulation visit, allowing for careful assessment of effects and potential side effects.
CONDITIONS
Brief Title
ADHD PreSMA Response Inhibition Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ADHD
- Aged between 12 and 17 years
- Stimulant medication allowed but must be stopped 24 hours before and during TMS visits
You will not qualify if you...
- History of intracranial pathology, epilepsy, seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, or hearing impairment
- Presence of any implanted medical devices such as ports, shunts, stimulators, or cochlear implants
- Current pregnancy for post-menarche females confirmed by urine test
- Baseline hearing impairment or chronic tinnitus
- Any significant abnormal brain MRI findings
- History of conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, or psychotic disorder
- Use of non-stimulant ADHD medications such as alpha2 adrenergic agonists, atomoxetine, or tricyclics
- Use of neuroleptic or antipsychotic medications
- Inability to undergo MRI
- Active or history of suicidality or high suicide risk
- Substance abuse or dependence within the past year except prescribed ADHD medication positive urine screen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including cognitive testing and brain MRI
Duration - 1 day
Participants receive two trains of intermittent theta burst stimulation (iTBS), a form of repetitive TMS. The first train is randomized to either active or sham stimulation, and the second train is active for all participants. Physiological and behavioral measures are collected before and immediately after each stimulation train.
1 visit (in-person) including baseline TMS measures, EEG recording during a behavioral task, iTBS delivery, and repeated assessments after stimulation
Duration - 1 day
Participants complete a virtual computer-based visit one week after stimulation to assess for any potential side effects.
1 virtual visit (remote)
Trial Site Locations
Total: 1 location
1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
K
Karlee Migneault, B.A.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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