Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury

Running, not enrolling

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 100 TBI patients and 100 controls.

Key facts

Study ID

NCT05092295

Run by

Rebiscan, Inc.

People needed

200

Starts

2021-12-01

Expected to finish

2025-12-31

Last updated by the study team

2025-04-04

Who can join

Age: 13 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 13-45 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 assent
• 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 of 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

• Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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