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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeBOX device | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive subjects who meet all of the inclusion criteria and none of the exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Rosina Samadani, PhD | Oculogica, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Sports Medicine Institute | White Plains | New York | 10604 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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diagnostic accuracy to identify increases or decreases in post-concussion symptom severity |
| up to one year after initial presentation |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |