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

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 100 TBI patients and 100 controls.

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

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Device: Head and Intraocular Trauma Tool
* Diagnostic Test: SCAT-5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TBI Patients<br>TBI participants 13 to 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. Enrollment is to occur within 2 weeks of the incident injury. | Device: Head and Intraocular Trauma Tool<br>* HITT device to scan eyes of participants up to 3 times ( 45 seconds each) at time of admittance to study. Participant is to place chin in chin-rest and fixate on illuminated light on device.<br>* Other names: HITT device;Diagnostic Test: SCAT-5<br>* Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.<br>* Other names: Sport Concussion Assessment Tool - 5th Edition;|
| 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. | Device: Head and Intraocular Trauma Tool<br>* HITT device to scan eyes of participants up to 3 times ( 45 seconds each) at time of admittance to study. Participant is to place chin in chin-rest and fixate on illuminated light on device.<br>* Other names: HITT device;Diagnostic Test: SCAT-5<br>* Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.<br>* Other names: Sport Concussion Assessment Tool - 5th Edition;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TBI Detection | Patients who have diagnosed TBI and are admitted to the hospital for treatment 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 have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI. | 14 days |