Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potential Traumatic Brain Injury | This group will consist of people admitted to the ER, Trauma Bay, or Neurosurgery for potential traumatic brain injury. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EyeBox CNS | Device |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants will include all patients evaluated for potential traumatic brain injury presenting to the Emergency Department or concussion clinic.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Uzma Samadani, M.D., Ph.D. | Hennepin County Medical Center, Minneapolis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SkyRidge Medical Center | Lone Tree | Colorado | 80124 | United States | ||
| Beaver Dam Community Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26487847 | Background | Samadani U. A new tool for monitoring brain function: eye tracking goes beyond assessing attention to measuring central nervous system physiology. Neural Regen Res. 2015 Aug;10(8):1231-3. doi: 10.4103/1673-5374.162752. No abstract available. | |
| 25582436 | Background | Samadani U, Ritlop R, Reyes M, Nehrbass E, Li M, Lamm E, Schneider J, Shimunov D, Sava M, Kolecki R, Burris P, Altomare L, Mehmood T, Smith T, Huang JH, McStay C, Todd SR, Qian M, Kondziolka D, Wall S, Huang P. Eye tracking detects disconjugate eye movements associated with structural traumatic brain injury and concussion. J Neurotrauma. 2015 Apr 15;32(8):548-56. doi: 10.1089/neu.2014.3687. Epub 2015 Feb 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Beaver Dam |
| Wisconsin |
| 53916 |
| United States |
| 25495739 | Background | Samadani U, Farooq S, Ritlop R, Warren F, Reyes M, Lamm E, Alex A, Nehrbass E, Kolecki R, Jureller M, Schneider J, Chen A, Shi C, Mendhiratta N, Huang JH, Qian M, Kwak R, Mikheev A, Rusinek H, George A, Fergus R, Kondziolka D, Huang PP, Smith RT. Detection of third and sixth cranial nerve palsies with a novel method for eye tracking while watching a short film clip. J Neurosurg. 2015 Mar;122(3):707-20. doi: 10.3171/2014.10.JNS14762. Epub 2014 Dec 12. |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D020196 | Trauma, Nervous System |
| D006259 | Craniocerebral Trauma |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
Not provided
Not provided