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Trial record 1 of 1 for:    neurodrive
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Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborators:
The Center for Neuroscience and Regenerative Medicine (CNRM)
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT02411227
First received: April 7, 2015
Last updated: July 26, 2017
Last verified: July 20, 2017
  Purpose

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 Intervention Phase
Traumatic Brain Injury Behavioral: VR Driving Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • VR Driving, Cognitive test, and Symptoms [ Time Frame: Ongoing ]

Secondary Outcome Measures:
  • MRI, Phenotyping, & Driving evals [ Time Frame: Ongoing ]

Enrollment: 37
Study Start Date: March 23, 2015
Study Completion Date: July 20, 2017
Primary Completion Date: July 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Immediate Intervention
Behavioral: VR Driving
Baseline: Tactical scenario, composite score Post-Assessment: Tactical scenario composite score
No Intervention: 2
Wait list

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Subjects eligible for participation must meet the following criteria:

  1. Currently has a valid driver s license, or had a valid driver s license prior to injury
  2. 18 years of age or older
  3. Able to effectively manipulate the steering wheel and the gas/brake pedals without adaptive equipment
  4. Able to read, write, and speak in English
  5. History of traumatic brain injury greater than 12 weeks prior to initiation into the current study
  6. Able to provide informed consent
  7. 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:

  1. 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.
  2. History of penetrating brain injury
  3. History of serious medical condition other than TBI that could affect cognitive or motor abilities (e.g., multiple sclerosis, encephalitis, cerebrovascular disease)
  4. History of severe motion sickness and/or vertigo.
  5. 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:

  1. 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.
  2. 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).
  3. 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02411227

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
The Center for Neuroscience and Regenerative Medicine (CNRM)
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Leighton Chan, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02411227     History of Changes
Other Study ID Numbers: 150103
15-CC-0103
Study First Received: April 7, 2015
Last Updated: July 26, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Neuropsychologic Testing
Neurocognitive
Virtual Reality
Rehabilitation
Driving

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 23, 2017