Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 12
Healthy Volunteers: t
View:

• 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.

Locations
United States
Maryland
Kennedy Krieger Institute
RECRUITING
Baltimore
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Donald L Gilbert, MD
donald.gilbert@cchmc.org
800-344-2462
Backup
Steve W Wu, MD
steve.wu@cchmc.org
800-344-2462
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 214
Treatments
Experimental: Attention Deficit Hyperactivity Disorder (ADHD)
8 to 12 year old children diagnosed with ADHD. Randomized, blinded, single dose, placebo controlled, crossover trial.
No_intervention: Typically developing controls (TDC)
Typically developing controls - 8 to 12 year old children
Sponsors
Collaborators: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Leads: Donald Gilbert, MD, MS, FAAN, FAAP

This content was sourced from clinicaltrials.gov