Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
Key facts
- Who runs it
- Donald Gilbert, MD, MS, FAAN, FAAP
- Where
- Baltimore and Cincinnati, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 214 people, planned
- Started
- 1 Sept 2020
- Expected to end
- 1 Mar 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Methylphenidate
- Placebo
- Record updated
- 25 September 2026
Who can take part
- Age
- 8 years to 12 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers
- 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
- 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)
- For females, onset of menses, pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 12 years old?
Where in United States
- Kennedy Krieger InstituteBaltimore, United StatesContact: Alyssa DeRondaTaking people
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Karlee MigneaultTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Attention Deficit Hyperactivity Disorder (ADHD)Treatment being tested
8 to 12 year old children diagnosed with ADHD. Randomized, blinded, single dose, placebo controlled, crossover trial.
Treatment: Methylphenidate and Placebo
- Typically developing controls (TDC)No study treatment, for comparison
Typically developing controls - 8 to 12 year old children
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function
- Fit questions
- Built from NCT04421248, who can take part
- Record updated
- 25 September 2026