Actively Recruiting
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
Led by Donald Gilbert, MD, MS, FAAN, FAAP · Updated on 2025-06-19
214
Participants Needed
2
Research Sites
291 weeks
Total Duration
On this page
Sponsors
D
Donald Gilbert, MD, MS, FAAN, FAAP
Lead Sponsor
H
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Either gender, any race, ethnicity or socioeconomic status
- Age between 8 years 0 months and 12 years 11 months
- Willing to answer questions about ADHD and related diagnoses
- For children prescribed stimulant medications, willing to suspend medications as specified
- Willing to participate in single dose, randomized crossover study with methylphenidate
- Right hand dominant
- Able to participate and provide informed consent
- ADHD diagnosis based on DSM-5 criteria using rating scales and structured interview; Oppositional Defiant Disorder allowed; Conduct Disorder excluded
- Typically developing children must be free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria
You will not qualify if you...
- Diagnosed with mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorders
- Diagnosed with Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, Anxiety Disorders, or other developmental psychiatric diagnoses
- Females who have started menstruation or are pregnant
- Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, or mood stabilizers
- Presence of implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port
- Diagnosis of speech/language disorder or Reading Disability (RD)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
D
Donald L Gilbert, MD
CONTACT
S
Steve W Wu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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