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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 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 37 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02411227
The ClinicalTrials.gov registry entry for NCT02411227 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VR Driving is the first listed.
NCT02411227 reports 0 study locations.
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.
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