Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.

Official Title
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Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

Conditions
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Brain Concussion, Cerebral Concussion, Concussion, Intermediate, Concussion, Mild, Concussion, Severe, Trauma, Nervous System, Craniocerebral Trauma, Brain Injuries

Intervention / Treatment
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* Device: EyeBox CNS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent. Be between the ages of 4 and 67 years old. Have a diagnosis of traumatic brain injury with a potential for concussion. Subjects must have baseline vision correctable to within 20/500 bilaterally. Subjects must have intact ocular motility. Subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior. Exclusion Criteria: ER visit has been more than 2 weeks since the injury which may have caused the concussion. Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read). Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability. Blind (no light perception), are missing eyes, do not open eyes. It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant. Previous history of: ocular motility dysfunction or extensive prior eye surgery. Any physical or mental injury or baseline disability rendering task completion difficult. Obvious intoxication or blood alcohol level greater than 0.2.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 67 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Potential Traumatic Brain Injury<br>This group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury. | Device: EyeBox CNS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in metrics of eye movement that enable positive concussion detection using BOX Score. | A True Positive rate for identifying Concussion as compared to a Clinical Reference standard. | Immediately after eye tracking, within 2 weeks of injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion. |  | Immediately before eye tracking, between 1 week and 109 weeks post injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye Tracking, Concussion, Outcome Measures