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This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.
EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT02957461 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injured and Matched Control Subject Pool | Injured subjects consist of subjects who are head injured and meet the inclusion/exclusion criteria. Injured subjects will be tested within 72 hours (3 days) of injury and at specified time points post injury. Matched control subjects will be tested at the same time intervals as the injured subject. BrainScope Battery will be performed at each time point and consists of the following components: brain electrical activity (EEG), neurocognitive performance assessment, ocular motor assessment, and clinical symptoms/assessments. |
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| Healthy Volunteer Subject Pool | This subject pool will consist of uninjured (not head injured) subjects and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainScope Ahead 300iP | Device | The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment, Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Likelihood of being concussed | Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI) | 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP |
| Measure | Description | Time Frame |
|---|---|---|
| Significance of change over time | Significant difference in concussion index between time of injury and return to play (RTP) | 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP |
| Prediction of prolonged recovery |
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Inclusion Criteria:
For Injured subjects:
For Matched Controls:
Exclusion Criteria:
For Injured subjects:
For Matched Controls:
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Approximately 160 Injured and Matched Control subjects will be recruited from high schools, college universities, concussion clinics and emergency rooms.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Prichep, Ph.D. | BrainScope Company, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Fayetteville | Arkansas | 72701 | United States | ||
| University of Miami |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index |
| 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP |
| Miami |
| Florida |
| 33136 |
| United States |
| Michigan State University | East Lansing | Michigan | 48824 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |