Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder

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.

Conditions

• Attention Deficit Hyperactivity Disorder Combined

Interventions

DRUG

Methylphenidate

In ADHD participants only: blinded, randomized, placebo-controlled single dose, crossover on separate days separated by at least one week.

DRUG

Placebo

In ADHD participants only: blinded, randomized, placebo-controlled, single dose, crossover on separate days separated by at least one week.

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  collaborator OTHER

• Donald Gilbert, MD, MS, FAAN, FAAP

  lead OTHER

Principal Investigators

• Donald L Gilbert, MD · Children's Hospital Medical Center, Cincinnati

• Stewart H Mostofsky, MD · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2026-02-09

Completion

2026-07-01

FDA Drug

Yes

Countries

• United States

Study Locations