Testing brain function measures in 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 clinical trial investigates the effects of a single dose of methylphenidate (MPH) on specific brain function biomarkers in children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Using Transcranial Magnetic Stimulation (TMS), the study aims to measure Short Interval Cortical Inhibition (SICI) and Task-Related Up-Modulation (TRUM) to better understand ADHD's neurophysiological underpinnings. The trial is designed as a randomized, blinded, placebo-controlled crossover study, allowing for a rigorous assessment of MPH's impact on these biomarkers. The ultimate goal is to enhance diagnostic accuracy and treatment personalization for children with ADHD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Either gender, any race, ethnicity or socioeconomic status
* Currently between 8 years 0 months and 12 years, 11 months, 30 days
* Willing to answer questions about ADHD and related diagnoses
* For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures
* For children with ADHD, willing to participate in the single dose, randomized crossover study to probe acute effects of methylphenidate on biomarkers
* Right hand dominant (predominately right-handed)
* Able to participate in and sign an informed consent
* ADHD inclusion: The diagnosis of ADHD will be based on Diagnostic and Statistical Manual version 5 (DSM-5) criteria using standard rating scales and a structured diagnostic interview. Oppositional Defiant Disorder is permitted; Conduct disorder is excluded.
* Typically Developing (healthy control) inclusion: Free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria using standard rating scales and a structured diagnostic interview.

Exclusion Criteria:

* Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder.
* Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses.
* For females, onset of menses, pregnancy.
* Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.
* Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port.
* Diagnosis of a speech/language disorder or a Reading Disability (RD).

Where it's running

• Kennedy Krieger Institute
  Baltimore, Maryland, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Donald L Gilbert, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Donald L Gilbert, MD
• Email: donald.gilbert@cchmc.org
• Phone: 800-344-2462

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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.