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

NCT02411227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2020-07-14

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

VR Driving

Baseline: Tactical A3 scenario, composite score Post-Assessment: Tactical A4 scenario composite score

Sponsors & Collaborators

  • The Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator UNKNOWN

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Leighton Chan, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-07
Primary Completion
2017-07-20
Completion
2020-07-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02411227 on ClinicalTrials.gov