Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury
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|ClinicalTrials.gov Identifier: NCT02411227|
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : May 23, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Behavioral: VR Driving||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury|
|Study Start Date :||April 7, 2015|
|Actual Primary Completion Date :||July 20, 2017|
|Actual Study Completion Date :||July 20, 2017|
Behavioral: VR Driving
Baseline: Tactical scenario, composite score Post-Assessment: Tactical scenario composite score
No Intervention: 2
- VR Driving, Cognitive test, and Symptoms [ Time Frame: Ongoing ]
- MRI, Phenotyping, & Driving evals [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|