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

ClinicalTrials.gov · COMPLETED, 2020

37 participants

Abstract

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…

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 37 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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