Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury
- 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.
- To test how NeuroDRIVE affects brain performance and driving safety.
- 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.
- 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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Evaluation of Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury|
- VR Driving, Cognitive test, and Symptoms [ Time Frame: Ongoing ]
- MRI, Phenotyping, & Driving evals [ Time Frame: Ongoing ]
|Study Start Date:||March 23, 2015|
|Study Completion Date:||July 20, 2017|
|Primary Completion Date:||July 20, 2017 (Final data collection date for primary outcome measure)|
Behavioral: VR Driving
Baseline: Tactical scenario, composite score Post-Assessment: Tactical scenario composite score
No Intervention: 2
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02411227
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Leighton Chan, M.D.||National Institutes of Health Clinical Center (CC)|