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NCT06142435RecruitingAccepts Healthy Volunteers

mTBI Identification and Monitoring Through Retinal Scanning

Rebiscan, Inc.

Start Date

8/15/2023

Completion Date

8/31/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to 45 years

Inclusion 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 Exclusion Criteria: 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

Interventions

DEVICE

Head and Intraocular Trauma Tool

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Conditions

Brain Injuries, Traumatic

Locations

Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University

Boston, Massachusetts 02215

United States