Clinical trialNCT02411227CompletedPhase 2Interventional

Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury

SponsorNational Institutes of Health Clinical Center (CC)Enrollment37Traumatic Brain Injury

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Leighton Chan, M.D.
National Institutes of Health Clinical Center (CC)
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 7 Apr 2015
Primary completion: 20 Jul 2017
Completion: 10 Jul 2020
Last update posted: 14 Jul 2020
Registered enrollment: 37
Registry id: NCT02411227

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.