mTBI Identification and Monitoring Through Retinal Scanning

Launched by REBISCAN, INC. · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Rebion trauma tool, which uses a special type of eye scan to help detect changes in eye movements that may indicate a traumatic brain injury (TBI). The goal is to see how well this device can identify problems with eye movement, alignment, and focus that could be related to brain injuries. The study will include 60 patients who have experienced a TBI and 20 healthy participants for comparison.

To be eligible for this trial, participants must be between 18 and 45 years old, have experienced head trauma within the last two weeks, and be able to give consent (or have a parent give consent if they are a minor). Participants should be able to follow simple instructions and speak either English or Spanish. Those with certain eye conditions or serious health issues related to brain injury may not qualify. If you choose to participate, you can expect to undergo an examination where your eye movements will be closely monitored to help researchers understand how this device works in detecting brain injuries.

Gender

ALL

Eligibility criteria

• 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