mTBI Identification and Monitoring Through Retinal Scanning

Recruiting now

Conditions studied: Brain Injuries, Traumatic

In brief

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.

Key facts

Study ID

NCT06142435

Run by

Rebiscan, Inc.

People needed

60

Starts

2023-08-15

Expected to finish

2026-08-31

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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