New York Sports Medicine Institute
White Plains, New York, 10604, United States
NCT Number: NCT03966404
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.
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Observational
White Plains, New York, 10604, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: day 0 (when patient first presents for evaluation)
sensitivity and specificity compared to initial clinical diagnosis of concussion
Time frame: up to one year after initial presentation
sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms
Time frame: through study participation, up to one year
adverse events occurring during use of the diagnostic device
Time frame: day 0 (when patient first presents for evaluation)
positive and negative predictive value compared to initial clinical diagnosis of concussion
Time frame: up to one year after initial presentation
diagnostic accuracy to identify increases or decreases in post-concussion symptom severity
Oculogica, Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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