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

NCT02411227 | Completed Phase 2

• 2 other identifiers: 15010315-CC-0103
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury

Keywords

Neuropsychologic Testing; Neurocognitive; Virtual Reality; Rehabilitation; Driving

Outcome Measures

Primary Outcomes (1)

• VR Driving, Cognitive test, and Symptoms

  -Results from the Virtual Reality Driving Assessment (baseline and post- intervention Tactical scenario composite scores)-Total scores on the Neurobehavioral Symptom Inventory-Standard and scaled scores from the following cognitive assessments (from the TBI Common Data Elements identified by NINDS):--WAIS-IV Digit Span subtest--WAIS-IV Digit-Symbol--Coding subtest

  pre/post after 16 weeks of intervention

Secondary Outcomes (1)

• MRI, Phenotyping, & Driving evals

  Ongoing

Study Arms (2)

1

EXPERIMENTAL

Immediate Intervention

Behavioral: VR Driving

2

NO INTERVENTION

Wait list

Interventions

VR Driving BEHAVIORAL

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible for participation must meet the following criteria:
• Currently has a valid driver s license, or had a valid driver s license prior to injury
• years of age or older
• Able to effectively manipulate the steering wheel and the gas/brake pedals without adaptive equipment
• Able to read, write, and speak in English
• History of traumatic brain injury greater than 12 weeks prior to initiation into the current study
• Able to provide informed consent
• NBSI score greater than or equal to 16 (Mild TBI sub-group only)

You may not qualify if:

• Subjects are not eligible for participation if any of the following conditions exist:
• Risk for injury from the MRI magnet, including:
• Pacemakers or other implanted electrical devices.
• Brain stimulators.
• Some types of dental implants.
• Aneurysm clips (metal clips on the wall of a large artery).
• Metallic prostheses (including metal pins and rods, heart valves, and cochlear implants).
• Permanent eyeliner (other non-metallic tattoos are permissible).
• Implanted delivery pump.
• Shrapnel fragments.
• Welders and metal workers are also at risk for injury because of possible small metal fragments in the eye of which they may be unaware.
• Fear of confined spaces.
• Back problems that may result in back pain or discomfort from lying in the scanner.
• Weight of over 350 pounds, due to the weight limit of the MRI table.
• History of penetrating brain injury

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• The Center for Neuroscience and Regenerative Medicine (CNRM): collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Ortoleva C, Brugger C, Van der Linden M, Walder B. Prediction of driving capacity after traumatic brain injury: a systematic review. J Head Trauma Rehabil. 2012 Jul-Aug;27(4):302-13. doi: 10.1097/HTR.0b013e3182236299.

  PMID: 21897289 BACKGROUND

• Cox DJ, Davis M, Singh H, Barbour B, Nidiffer FD, Trudel T, Mourant R, Moncrief R. Driving rehabilitation for military personnel recovering from traumatic brain injury using virtual reality driving simulation: a feasibility study. Mil Med. 2010 Jun;175(6):411-6. doi: 10.7205/milmed-d-09-00081.

  PMID: 20572473 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 8, 2015
• Study Start: April 7, 2015
• Primary Completion: July 20, 2017
• Study Completion: July 10, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Locations

US (1)