ADHD PreSMA Response Inhibition Therapy
Recruiting · NCT06325813 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati
View the official record on ClinicalTrials.gov →Interventions studied
Active repetitive TMSSham repetitive TMS
What this trial 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. 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.
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States