Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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. The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04421248
The ClinicalTrials.gov registry entry for NCT04421248 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Donald Gilbert, MD, MS, FAAN, FAAP, which has 1 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.