Actively Recruiting
Mild Traumatic Brain Injury Identification and Monitoring Through Retinal Scanning
Led by Rebiscan, Inc. · Updated on 2026-05-20
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rebiscan, Inc.
Lead Sponsor
B
Boston Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Rebion trauma tool, called the Head and Intraocular Trauma Tool (HITT), to detect changes in eye movements related to mild traumatic brain injury (mTBI). The study aims to assess how well this binocular retinal scan device can identify disruptions in ocular fixation, alignment, and saccades caused by brain injury. The trial will include 60 patients with mTBI and 20 uninjured control participants. Participants will be divided into two groups: controls without head trauma and TBI-suspected patients presenting with head trauma. The device will scan participants' eyes up to three times, each scan lasting about 45 seconds, where they place their chin on a rest and focus on a light. Testing will occur at three time points: at enrollment (Day 0), Day 14, and Day 30 to monitor changes over time. During the study, participants will undergo retinal scanning sessions and simple examinations to assess eye movement. Researchers will measure the device's ability to detect brain injury on Day 1 and monitor eye movement changes on Days 14 and 30. Participants must be able to follow instructions and communicate in English or Spanish. The study will last about one month per participant, with multiple assessments to track progress and safety.
CONDITIONS
Brief Title
mTBI Identification and Monitoring Through Retinal Scanning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 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 examination and follow simple instructions
- Fluent 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 or retinal diseases
- Known cataract
- History of neurosurgery
- History of stroke, brain hemorrhage, brain tumor, or epilepsy
- Any head trauma needing medical attention in last 6 months
- Diagnosed dementia or cognitive impairment needing daily help
- Under care of a neurologist for other conditions
- Psychiatric hospitalization in last 90 days
- Considered unsuitable by study staff
- Any minor brain injury regardless of loss of consciousness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 to Day 30
Participants undergo retinal scanning using the Head and Intraocular Trauma Tool (HITT) device up to 3 times to detect mild traumatic brain injury.
3 visits (Day 0, Day 14, and Day 30; in-person)
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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