What this study is
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity. They are at substantially increased risk for long-term difficulties into adulthood, including academic underachievement, substance abuse, and criminal behavior. The diagnosis of ADHD, which is based on subjective ratings by parents and teachers, likely results from multiple different, overlapping differences in circuits of the brain responsible for attention and impulse control. However, we do not have any scientific or clinical tests that allow us to understand these circuits. In an effort to improve ADHD outcomes, we have used a technology called Transcranial Magnetic Stimulation (TMS) to identify highly reliable measurements of brain function. We have identified two very promising measures that are abnormal in children with ADHD and, importantly, also predict the severity of ADHD behaviors. The goal of this project is to determine if these two TMS measurements could be used to help better guide ADHD treatment. To do this, we will perform three investigations in 8 to 12 year old children to determine: 1) test-retest reliability; 2) pharmacologic responsiveness; and 3) correlations with two domains of function relevant to ADHD: "Cognitive Control" and "Emotional Valence." Through these investigations, we aim to determine whether these two TMS brain measures are reliable and meaningful enough to be used to help improve precision of individually-targeted and effective ADHD treatments.
What's being tested
- Methylphenidate
Intervention · DRUG
In ADHD participants only: blinded, randomized, placebo-controlled single dose, crossover on separate days separated by at least one week.
- Placebo
Intervention · DRUG
In ADHD participants only: blinded, randomized, placebo-controlled, single dose, crossover on separate days separated by at least one week.
Study details
- Official title
- Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function
- Sponsor
- Donald Gilbert, MD, MS, FAAN, FAAP
- Conditions
- Attention Deficit Hyperactivity Disorder Combined
- Enrolling
- 214 people
- Starts
- 2020-09-01
- Est. completion
- 2027-03-01
- Design
- Triple-blind, randomized, crossover, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 8 Years – 12 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openKennedy Krieger Institute
Baltimore, Maryland, United States
- Alyssa DeRonda · Contact443-923-9528deronda@kennedykrieger.org
RecruitingCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
- Karlee Migneault · Contact513-803-2670karlee.migneault@cchmc.org
Recruiting
Study team
Sponsor
Donald Gilbert, MD, MS, FAAN, FAAP
Study ID CHMC IRB 2020-0297
Principal investigator
Donald L Gilbert, MD
Children's Hospital Medical Center, Cincinnati
Principal investigator
Stewart H Mostofsky, MD
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.