mTBI Identification and Monitoring Through Retinal Scanning

Study Overview
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Brief Summary
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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.

Official Title
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Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Device: Head and Intraocular Trauma Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Participants should not be part of the Intended Use Population. Subjects that present to the hospital, clinic, or emergency department, either as a patient or non-patient, with no history of head trauma and, are 18-45 years of age. | Device: Head and Intraocular Trauma Tool<br>* HITT device to scan the eyes of participants up to 3 times ( 45 seconds each) at the time of admittance to study. The participant is to place the chin in the chin-rest and fixate on the illuminated light on the device.<br>* Other names: HITT;|
| TBI-Suspected Patients<br>TBI participants 18-45 years of age, recruited from patients at a clinical research facility who present with head trauma. Clinical evaluation for the patient can be positive (target condition present) or negative (target condition absent) for mTBI. Testing will occur on Day-0, Day-14, and Day-30. | Device: Head and Intraocular Trauma Tool<br>* HITT device to scan the eyes of participants up to 3 times ( 45 seconds each) at the time of admittance to study. The participant is to place the chin in the chin-rest and fixate on the illuminated light on the device.<br>* Other names: HITT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBI Detection | Patients who present with suspected TBI to the clinic will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBI Monitor | Patients who present with suspected TBI to the clinic and had initially been tested for TBI detection will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI. | 14 days | 
| TBI Monitor | Patients who present with suspected TBI to the clinic and had initially been tested for TBI detection will receive a second set fo scans at one month to identify whether the HITT device can accurately identify patients with TBI. | 30 days |