Testing brain function measures in children with ADHD
Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function
PHASE4 · Children's Hospital Medical Center, Cincinnati · NCT04421248
This study is testing how a single dose of a common ADHD medication affects brain function in children with ADHD to help improve their treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati (other) |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT04421248 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 12 years diagnosed with ADHD who are willing to participate in the study and suspend their current stimulant medications.
Not a fit: Patients with conduct disorder or those who are not right-hand dominant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more precise and effective treatment strategies for children with ADHD.
How similar studies have performed: Other studies have explored brain function measures in ADHD, but this specific approach using TMS and biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland and 1 other locations
- 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
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.
Conditions: Attention Deficit Hyperactivity Disorder Combined