Testing a Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or HITT), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically confirmed traumatic brain inju...

About

Protocol Description

This study involves a single, approximately one-hour-long session during which subjects will first be asked to provide basic identifying personal information. They will then be asked to sit at a table and look into a non-invasive device called the Rebion trauma tool: a gray object approximately the size of a soccer ball that can detect and analyze eye movements to aid in assessing mild traumatic brain injuries (mTBIs). Subjects' only task is to follow a target of light with their eyes as it changes location. A single complete test takes between 25 and 45 seconds, and subjects will be asked to complete up to four scans with a 30-second break between scans. Subjects who had a head injury will be asked to complete a questionnaire about their brain function and how they feel. Subjects will not be provided with the results of these scans during this study or after the study has concluded.

Eligibility Criteria

Inclusion Criteria

  1. Between the ages of 10 and 45
  2. Presents to the ED within two weeks of head trauma
  3. Able to provide informed consent
  4. Able to participate in the examination, including having the ability to follow simple instructions
  5. Visual acuity of 20/200 or better

Exclusion Criteria

  1. GCS <13, as presented in ED at time of screening
  2. Under the influence of alcohol or drugs
  3. Known eye disease, including previous eye surgery (including laser surgery), visual acuity known to be 20/200 or less in either eye, known strabismus (crossed eyes, amblyopia or double vision), known eye movement disorder including nystagmus, known optic nerve disease including papilledema, optic neuropathy, known retinal disease including macular degeneration or retinal degeneration, or known cataract
  4. Known brain injury, including history of neurosurgery, history of stroke/brain hemorrhage, brain tumor or epilepsy, or any head trauma requiring medical attention from a physician within the prior six months
  5. Known neurologic disease or history of diagnosed dementia or cognitive impairment requiring assistance for daily living, or other condition(s) under the care of a neurologist
  6. Other conditions, including psychiatric hospitalization in the prior 90 days
  7. Subject considered unsuitable for participation in this clinical trial by PI, treating clinical or study research staff

Primary Investigator

Damon R. Kuehl, M.D.

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Damon Kuehl, M.D., is an Emergency Medicine physician with over 20 years of clinical and research experience. He is an associate professor of Emergency Medicine at the Virginia Tech Carilion School of Medicine and vice chair of Research and Academic Affairs at Carilion Clinic. He is board certified by American Board of Emergency Medicine in Emergency Medicine. He attended the University of Minnesota for Medical School and completed his emergency training at Stanford University. He completed a health research fellowship in health policy and economics at Oregon Health and Science University.

Damon R. Kuehl, M.D.

Contact Information

Sophia Corazza, B.S.
Clinical Research Coordinator

Jared Gordon, M.D.
Clinical Research Coordinator