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.
Study Type
OBSERVATIONAL
Enrollment
200
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.
New York Sports Medicine Institute
White Plains, New York, United States
diagnostic accuracy of initial clinical diagnosis of concussion
sensitivity and specificity compared to initial clinical diagnosis of concussion
Time frame: 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
Time frame: up to one year after initial presentation
adverse events
adverse events occurring during use of the diagnostic device
Time frame: through study participation, up to one year
diagnostic accuracy of initial clinical diagnosis of concussion
positive and negative predictive value compared to initial clinical diagnosis of concussion
Time frame: 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
Time frame: up to one year after initial presentation
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