mTBI Identification and Monitoring Through Retinal Scanning

Description

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 injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.

Conditions

Brain Injuries, Traumatic

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Study Overview

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Study Details

Study overview

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 injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.

Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning

mTBI Identification and Monitoring Through Retinal Scanning

Condition
Brain Injuries, Traumatic
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University, Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 18-45 years
  • 2. Presents to the facility within 2 weeks of head trauma
  • 3. Able to provide informed consent
  • * If minor, then able to provide parental consent and minor consent
  • 4. Able to participate in the examination, including the ability to follow simple instructions
  • 5. Fluency in English or Spanish
  • 1. Glasgow Coma Scale score equal to or less than 13 at the time of study enrollment
  • 2. Under the influence of alcohol or drugs
  • 3. Previous eye surgery
  • 4. Visual acuity known to be 20/200 or less in either eye
  • 5. Known strabismus, amblyopia (lazy eye), or double vision
  • 6. Known eye movement disorder, including nystagmus
  • 7. Known optic nerve disease, including papilledema or optic neuropathy
  • 8. Known retinal disease, including macular degeneration or retinal degeneration
  • 9. Known cataract
  • 10. History of neurosurgery
  • 11. History of stroke/brain hemorrhage, brain tumor, or epilepsy
  • 12. Any head trauma requiring medical attention from a physician within the last 6 months
  • 13. Diagnosed dementia or cognitive impairment requiring assistance for daily living
  • 14. Other condition(s) under the care of a neurologist
  • 15. Psychiatric hospitalization in the last 90 days
  • 16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff
  • 17. Any minor brain injury regardless of loss of consciousness

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Rebiscan, Inc.,

Study Record Dates

2024-08-31