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The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients under evaluation for Suspected Concussion | Device: EyeBOX Model EBX-4 (Portable version) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeBOX Model EBX-4 (Portable version) | Diagnostic Test | The portable EyeBOX takes less than 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high-speed camera continuously records gaze positions. The Portable EyeBOX software detects subtle changes in eye movements consistent with concussion and calculates a BOX score. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of initial clinical diagnosis of concussion | Sensitivity and Specificity compared to the initial 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 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 to identify increases or decreases in post-concussion symptom severity | Correlation with increases or decreases in post-concussion symptom severity | Up to one year after initial presentation |
| Subgroup analyses |
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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 |
| Amy Romandine-Kratz, MD | Prevea Health | Principal Investigator |
| Mario Chavez, DC | Redlands Chiropractic | Principal Investigator |
| Brian Lease, PT | Westfields Hospital | Principal Investigator |
| Yang K Lo, MD | CentraCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Redlands Chiropractic | Redlands | California | 92373 | United States | ||
| CentraCare |
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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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Subgroup analyses will be performed by age, gender, and days since incident injury
| Up to one year after initial presentation |
| 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) |
| Saint Cloud |
| Minnesota |
| 56303 |
| United States |
| Prevea Health | Green Bay | Wisconsin | 54303 | United States |
| Westfields Hospital | New Richmond | Wisconsin | 54017 | United States |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |