Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury
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| ClinicalTrials.gov Identifier: NCT02411227 |
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Recruitment Status :
Completed
First Posted : April 8, 2015
Last Update Posted : July 14, 2020
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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.
| 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 |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury |
| Actual Study Start Date : | April 7, 2015 |
| Actual Primary Completion Date : | July 20, 2017 |
| Actual Study Completion Date : | July 10, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Immediate Intervention
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Behavioral: VR Driving
Baseline: Tactical A3 scenario, composite score Post-Assessment: Tactical A4 scenario composite score |
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No Intervention: 2
Wait list
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- VR Driving, Cognitive test, and Symptoms [ Time Frame: pre/post after 16 weeks of intervention ]-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
- MRI, Phenotyping, & Driving evals [ Time Frame: Ongoing ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
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
- 18 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)
EXCLUSION CRITERIA:
Subjects are not eligible for participation if any of the following conditions exist:
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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.
- It is not known if MRI is completely safe for a developing fetus. Therefore, all women of childbearing potential will have a pregnancy test performed no more than 24 hours before each MRI scan. The scan will not be done if the pregnancy test is positive. Because neuroimaging is a key component of the current study, inability to participate in MRI scanning is a necessary exclusion criterion.
- History of penetrating brain injury
- History of serious medical condition other than TBI that could affect cognitive or motor abilities (e.g., multiple sclerosis, encephalitis, cerebrovascular disease)
- History of severe motion sickness and/or vertigo.
- Other medical or psychological instability that could create difficulty fulfilling the study requirements (e.g., untreated mental illness, auditory/visual hallucinations, narcolepsy)
To verify this information, study coordinators will request medical records (i.e., recent medical history, medication list, any neuroimaging, and records pertinent to the participant s recent injury) to further evaluate potential participants inclusion into the study. Medical records can be obtained in three ways:
- Participants can bring the records when they come to NIH for testing; it will be made clear if they do not bring this information with them and we cannot verify that they meet inclusion criteria, potential participants will not be enrolled into the study that day.
- Alternatively, the participants can also fax their medical records to a secured fax machine at the Recreational Therapy office at the NIH where access is only permitted to study staff (i.e., scheduler, physician, and nurse psychologist).
- Participants may also fill out a medical release document and submit it to the study coordinator.
Medical history data will be reviewed, and if it is clear that the patient does not meet the inclusion criteria, we will contact them and cancel their appointment. Data obtained in this manner may be used to evaluate participant eligibility; however, it will not be used for any research purposes. Additionally, for any patients who are deemed not eligible to participate, their medical history data will be destroyed in accordance with NIH regulations.
As a condition of receiving funding from CNRM, de-identified imaging and phenotyping data (i.e., neurocognitive test results and behavioral questionnaires) from funded studies must be made available within a centralized repository (the CNRM Informatics Core) one year after the completion of the study. This is intended to facilitate use and analysis of this data for future research questions or projects. As such, potential subjects will be informed that they should not participate in this study if they do not want their data used for other projects.
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) |
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT02411227 |
| Other Study ID Numbers: |
150103 15-CC-0103 |
| First Posted: | April 8, 2015 Key Record Dates |
| Last Update Posted: | July 14, 2020 |
| Last Verified: | July 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Neuropsychologic Testing Neurocognitive Virtual Reality Rehabilitation Driving |
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Brain Injuries Brain Injuries, Traumatic Wounds and Injuries Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |