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NCT04421248 · ClinicalTrials.gov registry record · Phase 4
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
A Phase 4 study of Attention Deficit Hyperactivity Disorder Combined, sponsored by Donald Gilbert, MD, MS, FAAN, FAAP.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 214
- Enrollment target
- 2
- Study locations
NCT04421248: Recruiting Phase 4 study of Attention Deficit Hyperactivity Disorder Combined, sponsored by Donald Gilbert, MD, MS, FAAN, FAAP.
NCT04421248 is a Phase 4 study of Attention Deficit Hyperactivity Disorder Combined that is actively recruiting participants, run by Donald Gilbert, MD, MS, FAAN, FAAP. The registered enrollment target is 214 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04421248, a Phase 4 study of Attention Deficit Hyperactivity Disorder Combined, is actively recruiting participants, sponsored by Donald Gilbert, MD, MS, FAAN, FAAP.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 214 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
A ratio of amplitudes of motor evoked potentials from paired (inhibitory) and single TMS pulses, obtained from dominant motor cortex with hand at rest
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Methylphenidate
Study Locations (2)
Maryland
- Kennedy Krieger Institute - Baltimore
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 4 |
What NCT04421248 shows while recruiting
NCT04421248 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder Combined appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04421248 reports a single indexed study location in Maryland, Ohio.
Frequently Asked Questions
What is clinical trial NCT04421248 about?
NCT04421248 is a clinical study titled "Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder". 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 difficul...
What is the current status of trial NCT04421248?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 214 participants. The study started on 2020-09-01. Estimated completion is 2026-04-01.
What conditions does trial NCT04421248 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder Combined.
What interventions are being tested in trial NCT04421248?
The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT04421248?
This trial is sponsored by Donald Gilbert, MD, MS, FAAN, FAAP, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04421248 being conducted?
This trial has 2 study locations across Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04421248's enrollment target sits among peer trials
214 394th of 2000 higher than 1,606 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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