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NCT02260570 · ClinicalTrials.gov registry record · Early Phase 1
Remediation of Impaired Self-Regulation in Patients With Mild TBI
A Early Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 55
- Enrollment target
NCT02260570: Completed Early Phase 1 study, sponsored by VA Office of Research and Development.
NCT02260570 is a Early Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 55 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02260570, a Early Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
The ability to regulate impulses enables us to plan for the future, to maintain focus in the face of distractions (i.e. to encode memories), and to manage emotions. This self regulation can be compromised in individuals who have a history of mild traumatic brain injury and co-occurring disorders. In this study the investigators are using functional MRI scanning to understand how memory and self regulation are expressed in the brains of people with a history of mild traumatic brain injury. The investigators are also testing whether the medication tolcapone may improve memory and self regulation.
Primary Outcome
Functional MRI measures blood flow changes. Blood Oxygen Level Dependent (BOLD) signals provide an indirect unitless measure of brain activity typically described as a percentage. However, because fMRI data sets are large (\> 10,000 comparisons), analysis packages present results as F statistics or similar measures for individual voxels across the brain. Thus, no single mean or median value describes the 3-way interaction between drug (tolcapone minus placebo), stimulus emotion (neutral versus a
Interventions
- DRUG Placebo
- DRUG Tolcapone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2015-08-01 |
| Est. Completion | 2021-06-30 |
| Phase | Early Phase 1 |
What the finished NCT02260570 record still lists
NCT02260570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02260570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02260570 about?
NCT02260570 is a clinical study titled "Remediation of Impaired Self-Regulation in Patients With Mild TBI". The ability to regulate impulses enables us to plan for the future, to maintain focus in the face of distractions (i.e. to encode memories), and to manage emotions. This self regulation can be compromised in individuals who have a history of mild traumatic brain injury and co-occurring disorders. In...
What is the current status of trial NCT02260570?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 55 participants. The study started on 2015-08-01. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT02260570?
The interventions under investigation include: Placebo (DRUG), Tolcapone (DRUG).
Who is sponsoring clinical trial NCT02260570?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02260570's enrollment target sits among peer trials
55 458th of 2000 higher than 1,538 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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