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NCT02411227 · ClinicalTrials.gov registry record · Phase 2
Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
NCT02411227: Completed Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT02411227 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02411227, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
Study Summary
Background: \- People with traumatic brain injury (TBI) can have problems with thinking and everyday activities. They may have a higher risk for car accidents. NeuroDRIVE uses a virtual reality driving simulator. Researchers think it can help test and improve how people think and drive after TBI. Objective: \- To test how NeuroDRIVE affects brain performance and driving safety. Eligibility: \- People at least 18 years old with a history of TBI and who had a driver s license at some point. They must speak, read, and write English and be physically able to drive. Design: * Participants will be asked to release their driving records, but they do not have to do this to be in the study. * Visit 1: Screening physical exam. * Visit 2: Magnetic resonance imaging (MRI) scan. Participants will lie on a table that slides into a cylinder with a strong magnetic field. A device will be placed over the head. Participants may do computer tasks during the scan. * Participants will have tests of memory, attention, and thinking. They may be asked questions, take tests, and do simple actions. * Visit 3: Tests of memory, attention, and thinking, plus a virtual reality driving assessment. * Participants will be assigned to Group 1 to start NeuroDRIVE training immediately or Group 2 to start 10 weeks later. * Visits 4 9, over 4 weeks: * Participants will practice driving skills and mental exercises in the simulator. * They will complete a driving questionnaire online each week. * Visit 10: Repeat of Visit 3, with some small changes. * Visits 11-12: Very similar to Visits 1-2. Includes MRI scan; physical exam; questionnaires; and tests of thinking, memory, and attention.. * After Visit 12: Participants will fill out a weekly driving survey online for 4 weeks.
Primary Outcome
-Results from the Virtual Reality Driving Assessment (baseline and post- intervention Tactical scenario composite scores)-Total scores on the Neurobehavioral Symptom Inventory-Standard and scaled scores from the following cognitive assessments (from the TBI Common Data Elements identified by NINDS):--WAIS-IV Digit Span subtest--WAIS-IV Digit-Symbol--Coding subtest
Interventions
- BEHAVIORAL VR Driving
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2015-04-07 |
| Est. Completion | 2020-07-10 |
| Phase | Phase 2 |
What the finished NCT02411227 record still lists
NCT02411227 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which VR Driving is the first listed.
NCT02411227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02411227 about?
NCT02411227 is a clinical study titled "Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury". Background: \- People with traumatic brain injury (TBI) can have problems with thinking and everyday activities. They may have a higher risk for car accidents. NeuroDRIVE uses a virtual reality driving simulator. Researchers think it can help test and improve how people think and drive after TBI. ...
What is the current status of trial NCT02411227?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2015-04-07. Estimated completion is 2020-07-10.
What interventions are being tested in trial NCT02411227?
The interventions under investigation include: VR Driving (BEHAVIORAL).
Who is sponsoring clinical trial NCT02411227?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02411227's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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