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

Traumatic Brain Injury Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

OBJECTIVE:

The primary objective of this study is to evaluate the NeuroDRIVE behavioral intervention for enhancement of driving abilities, cognitive abilities, and neurobehavioral symptoms after traumatic brain injury (TBI). For the purposes of this protocol, NeuroDRIVE refers to the novel combined approach of driving training and cognitive rehabilitation in a virtual reality environment. While NeuroDRIVE utilizes the VR system as the method through which the intervention is administered, NeuroDRIVE is not the VR system itself.

STUDY POPULATION:

30 adult patients with a history of mild TBI and 30 adult patients with a history of moderate-to-severe TBI. Participants will be recruited from the National Institutes of Health (NIH), WRNMMC, and the broader community.

DESIGN:

The current study is a Clinical Trial Phase II interventional research study. The primary purpose of the study is for treatment, and it will employ a parallel intervention model. There will be no masking (i.e., open label). Participants will be classified into two groups by TBI severity: those with history of mild TBI and those with history of moderate-tosevere TBI. These different severities are known to have distinct cognitive sequelae. Within each severity group, participants will be in a 2 (pre-post) x 2 (treatment vs. wait list) experimental design.

OUTCOME MEASURES:

Primary outcome measures will include:

• Results from the Virtual Reality Driving Assessment (baseline and postintervention 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 or WMS-IV Digit Span subtest

WAIS-IV Digit-Symbol Coding subtest

Secondary outcome measures will include:

-Neuroimaging results:

Regions of Interest for FMRI: Bilateral dorsolateral prefrontal cortex

Regions of Interest for DTI: Corpus callosum, bilateral frontal white matter horns, and bilateral longitudinal fasciculi

-Total scores on the following symptom questionnaires:

Glasgow Outcome Scale-Extended (GOS-E)

Ohio State University TBI Identification Method

Brief Symptom Inventory- 18

Satisfaction with Life Scale (SWLS)

PTSD Checklist- Civilian (PCL-C)

SF-36v2 Health Survey (SF-36v2)

Fatigue Severity Scale (FSS)

Epworth Sleepiness Scale (ESS)

Beck Depression Inventory-II (BDI-II)

Combat Exposure Scale (CES)

Dual Dangerous Driving Index (DDDI)

-Standard and scaled scores from the following cognitive phenotyping assessments (from the TBI Common Data Elements identified by NINDS):

California Verbal Learning Test- Second Edition (CVLT-II)

WAIS-IV Symbol Search subtest

Medical Symptom Validity Test (MSVT)

-Standard and scaled scores from the following additional cognitive phenotyping assessments:

Trail Making Test (TMT)

Test of Premorbid Functioning (ToPF)

Grooved Pegboard

Controlled Oral Word Association Test (COWAT)

Bethesda Eye and Attention Measure (BEAM) ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT02411227
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 2
• Start date: April 7, 2015
• Completion date: July 10, 2020