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.
Study Type
OBSERVATIONAL
Enrollment
309
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.
University of Arkansas
Fayetteville, Arkansas, United States
University of Miami
Miami, Florida, United States
Michigan State University
East Lansing, Michigan, United States
Washington University
St Louis, Missouri, United States
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)
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Significance of change over time
Significant difference in concussion index between time of injury and return to play (RTP)
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Prediction of prolonged recovery
Accuracy of prediction of prolonged recovery from injury assessment using a multi-modal EEG-based concussion index
Time frame: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
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University of Rochester
Rochester, New York, United States