EyeBOX Concussion Study and Registry

Study Overview
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Brief Summary
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The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.

Official Title
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EyeBOX Concussion Study and Registry

Conditions
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Concussion, Brain, Mild Traumatic Brain Injury

Intervention / Treatment
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* Diagnostic Test: EyeBOX device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent or assent along with guardian consent. Have sustained a suspected direct or indirect force to the head with or without documented loss of consciousness, memory loss, alteration in consciousness or neurologic deficits. Only individuals presenting for initial evaluation of concussion may be enrolled, however longitudinal assessments may be conducted on enrolled subjects. Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking. Exclusion Criteria: Have penetrating trauma. Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read). Either of the following conditions, immediately related to the incident head trauma: loss of consciousness exceeding 30 minutes or best available GCS score less than 13 within 24 hours. Be blind (no light perception), have missing or non-functional eyes. Be unable to open their eyes. Have a history of unresolved strabismus, diplopia, amblyopia. Have a history of unresolved cranial nerve III, IV, or VI palsy. Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption. Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring. Have a prior history of unresolved ocular-motor dysfunctions. Be intoxicated.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: EyeBOX device|The EyeBOX medical device tracks a patient's eye movement and calculates a BOX Score ranging from 0-20. The BOX score is interpreted as a binary classification for eye movement abnormalities, where anything equal to or greater than 10 is a positive result for the initial evaluation of concussion and everything below 10 is negative.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of initial clinical diagnosis of concussion | sensitivity and specificity compared to initial clinical diagnosis of concussion | day 0 (when patient first presents for evaluation) | 
| diagnostic accuracy of clinical diagnosis of post-concussion symptoms | sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms | up to one year after initial presentation | 
| adverse events | adverse events occurring during use of the diagnostic device | through study participation, up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of initial clinical diagnosis of concussion | positive and negative predictive value compared to initial clinical diagnosis of concussion | day 0 (when patient first presents for evaluation) | 
| correlation with increases or decreases in post-concussion symptom severity | diagnostic accuracy to identify increases or decreases in post-concussion symptom severity | up to one year after initial presentation |