Actively Recruiting
mTBI Identification and Monitoring Through Retinal Scanning
Led by Rebiscan, Inc. · Updated on 2025-04-06
60
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
R
Rebiscan, Inc.
Lead Sponsor
B
Boston Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
mTBI Identification and Monitoring Through Retinal Scanning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-45 years
- Presents to the facility within 2 weeks of head trauma
- Able to provide informed consent or parental consent if minor
- Able to participate in the examination, including the ability to follow simple instructions
- Fluency in English or Spanish
You will not qualify if you...
- Glasgow Coma Scale score 13 or less at enrollment
- Under the influence of alcohol or drugs
- Previous eye surgery
- Visual acuity 20/200 or worse in either eye
- Known strabismus, amblyopia, or double vision
- Known eye movement disorders including nystagmus
- Known optic nerve diseases including papilledema or optic neuropathy
- Known retinal diseases including macular or retinal degeneration
- Known cataract
- History of neurosurgery
- History of stroke, brain hemorrhage, brain tumor, or epilepsy
- Any head trauma requiring medical attention in the last 6 months
- Diagnosed dementia or cognitive impairment needing daily living assistance
- Other neurological conditions under specialist care
- Psychiatric hospitalization within the last 90 days
- Considered unsuitable by study staff or clinicians
- Any minor brain injury regardless of loss of consciousness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University
Boston, Massachusetts, United States, 02215
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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