Status:
RECRUITING
mTBI Identification and Monitoring Through Retinal Scanning
Lead Sponsor:
Rebiscan, Inc.
Collaborating Sponsors:
Boston Medical Center
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
18-45 years
Brief 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. Preli...
Eligibility Criteria
Inclusion
- Age 18-45 years
- Presents to the facility within 2 weeks of head trauma
- Able to provide informed consent
- If minor, then able to provide parental consent and minor consent
- Able to participate in the examination, including the ability to follow simple instructions
- Fluency in English or Spanish
Exclusion
- Glasgow Coma Scale score equal to or less than 13 at the time of study enrollment
- Under the influence of alcohol or drugs
- Previous eye surgery
- Visual acuity known to be 20/200 or less in either eye
- Known strabismus, amblyopia (lazy eye), or double vision
- Known eye movement disorder, including nystagmus
- Known optic nerve disease, including papilledema or optic neuropathy
- Known retinal disease, including macular degeneration or retinal degeneration
- Known cataract
- History of neurosurgery
- History of stroke/brain hemorrhage, brain tumor, or epilepsy
- Any head trauma requiring medical attention from a physician within the last 6 months
- Diagnosed dementia or cognitive impairment requiring assistance for daily living
- Other condition(s) under the care of a neurologist
- Psychiatric hospitalization in the last 90 days
- Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff
- Any minor brain injury regardless of loss of consciousness
Key Trial Info
Start Date :
August 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06142435
Start Date
August 15 2023
End Date
August 31 2025
Last Update
April 6 2025
Active Locations (1)
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1
Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University
Boston, Massachusetts, United States, 02215