An observational study in Brain Injuries, Traumatic, Concussion, Mild and Concussion, Brain, sponsored by BrainScope Company, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by BrainScope Company, Inc. · Observational
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 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 NCT03671083 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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 420 is above the median of 100 across 690 observational studies indexed under Brain Injuries.
Browse Brain Injuries studies →BrainScope Company, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Approximately 220 male and female student-athletes from participating universities or colleges will be invited to participate.
Exclusion Criteria:
Injured subjects consist of athletes 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.
Device: BrainScope Ahead 200iD
This subject pool will consist of uninjured (not head injured) contact and non-contact athletes and will be tested at a single time point. These subjects will perform the same BrainScope Battery as the injured and matched control subjects.
Device: BrainScope Ahead 200iD
The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG.
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
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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BrainScope Company, Inc.