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This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.
Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points following injury. 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. This data will be used to populate a database for the purpose of deriving a multimodal concussion index.
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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 and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Derivation of algorithm for Likelihood of being concussed using multimodal inputs | Create a database of all assessments including brain electrical activity (EEG features including all frequency bands and measures (power, connectivity,complexity), neurocognitive performance tests scores (throughput measures), balance, and clinical/symptom assessments (SCAT5), to support derivation of a multimodal brain function/concussion index. (NOTE: All EEG and Neurocognitive features are expressed as z-scores relative to age expected normal values to enable combination) | 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP |
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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 490 Injured, Matched Control and Healthy Volunteer 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32228157 | Derived | Covassin T, McGowan AL, Bretzin AC, Anderson M, Petit KM, Savage JL, Katie SL, Elbin RJ, Pontifex MB. Preliminary investigation of a multimodal enhanced brain function index among high school and collegiate concussed male and female athletes. Phys Sportsmed. 2020 Nov;48(4):442-449. doi: 10.1080/00913847.2020.1745717. Epub 2020 Mar 31. |
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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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|
| Miami |
| Florida |
| 33136 |
| United States |
| Michigan State University | East Lansing | Michigan | 48824 | 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 |