Therapy using brain stimulation for children with ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.