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NCT04349917 · ClinicalTrials.gov registry record · Phase 4
Large-scale Brain Organization During Cognitive Control in ADHD
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT04349917: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT04349917 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04349917, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether children with attention-deficit/hyperactivity disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in response to shifting cognitive demands during the exertion of cognitive control, by assessing changes in network dynamics resulting from stimulant administration in children with ADHD, and how those changes relate to behavioral and symptom improvements. Subjects will be children with ADHD aged 8-12. Subjects will participate in multiple testing sessions that include: diagnosis and eligibility screening, neuropsychological and behavioral testing, and, if eligible, MRI scans and a medication challenge. Children with ADHD who are enrolled in the medication challenge will undergo one MRI scan on placebo and one MRI scan on stimulant medication, counterbalanced and double-blind. Functional connectivity will be measured using functional MRI and innovative graph theoretical analytic tools will be implemented. Network metrics will be related to symptomatology and behavioral testing measures. It is hypothesized that stimulant administration in children with ADHD will increase flexibility in network reconfiguration in response to changing cognitive control demands as compared to when they are on placebo. It is further hypothesized that the degree to which brain network organization is changed will be related to the degree of improvement in cognitive control performance.
Primary Outcome
Assessment of network topology during a resting state using functional connectivity estimates. Modularity will be determined by applying graph theoretical methods to functional connectivity estimates acquired during functional magnetic resonance imaging (fMRI) scans. Modularity is measured on a -1 to 1 scale, with higher scores indicating stronger community structure, or a stronger tendency of clusters of brain regions to separate into distinct, highly interconnected networks with sparse connect
Interventions
- OTHER Placebo
- DRUG Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-12-16 |
| Est. Completion | 2020-03-14 |
| Phase | Phase 4 |
What the finished NCT04349917 record still lists
NCT04349917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04349917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04349917 about?
NCT04349917 is a clinical study titled "Large-scale Brain Organization During Cognitive Control in ADHD". The purpose of this study is to test whether children with attention-deficit/hyperactivity disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in response to shifting cognitive demands during the exertion of cognitive control, by assessing changes in network dyna...
What is the current status of trial NCT04349917?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2016-12-16. Estimated completion is 2020-03-14.
What interventions are being tested in trial NCT04349917?
The interventions under investigation include: Placebo (OTHER), Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT04349917?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04349917's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 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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