Therapy using brain stimulation for children with ADHD
ADHD PreSMA Response Inhibition Therapy
This study is testing whether a special brain stimulation treatment can help children with ADHD improve their ability to control their impulses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06325813 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Transcranial Magnetic Stimulation (TMS) on children aged 12-17 diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Participants will undergo cognitive testing and brain MRI, followed by baseline measures of inhibitory control. They will receive two trains of Intermittent Theta Burst Stimulation (iTBS), with the first being randomized between active and sham stimulation. The study aims to assess changes in inhibitory control through behavioral tasks and EEG data collection before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 12-17 with a diagnosis of ADHD who can temporarily discontinue stimulant medications.
Not a fit: Patients with significant medical conditions, implanted devices, or other psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could improve inhibitory control in children with ADHD, potentially leading to better management of their symptoms.
How similar studies have performed: Previous studies using TMS for ADHD have shown promising results, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Steve W Wu, M.D. — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Karlee Migneault, B.A.
- Email: Karlee.Migneault@cchmc.org
- Phone: 513-803-5299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.