The objectives of the study are to document device performance with respect to the primary and secondary endpoints.
The purpose of the current study is proposed to prospectively validate the BrainScope Ahead® M-100 device design, performance, and labeling with respect to the device's target intended use and indications for use: * Primary Endpoint: * Structural Injury Assessment * There are four co-primary endpoints in this study: two sets of sensitivity and specificity to divide the data into three classes. * Using a BrainScope classification algorithm, the Ahead® M100 will identify subjects showing sensitivities among 3 classes: Green-normal, nonhead injured controls,Yellow-head injured subjects who do not exhibit brain electrical activity that is consistent with a structural brain injury observable on CT or for whom CT was not deemed necessary,Red-head injured subjects who exhibit brain electrical activity consistent with a structural brain injury observable by CT. * Secondary Endpoint: * Functional Injury Assessment * There are two co-secondary endpoints for the secondary objective, the sensitivity and specificity to split Yellow from the primary endpoint into two sub groups depending on degree of brain functional impairment observable by an evaluation of the clinical findings on a clinical charter used as the assessment of truth.
Study Type
OBSERVATIONAL
Enrollment
816
Hartford Hospital
Hartford, Connecticut, United States
University of Maryland R Cowley Shock Trauma Center
Baltimore, Maryland, United States
Sinai Hospital
Baltimore, Maryland, United States
Structural Brain Injury Assessment
Using a BrainScope classification algorithm, the Ahead® M-100 will identify subjects showing sensitivities among 3 classes: Green - brain electrical activity that is consistent with patients without head injuries (Ahead® M-100 output = 1), Yellow - brain electrical activity that is consistent with head injured subjects who are abnormal, but do not have a structural brain injury (Ahead® M-100 output = 2 or 3), Red - brain electrical activity consistent with a structural brain injury observable on CT (Ahead® M-100 output = 4).
Time frame: within 24 hours of injury
Functional Brain Injury Assessment
The sensitivity and specificity to split Yellow from the primary endpoint into two sub groups depending on degree of brain functional impairment observable by an evaluation of the clinical findings on the BrainScope Clinical Charter Patients classified as Yellow (b) will exhibit brain electrical activity consistent with more severe brain functional impairment. Patients classified as Yellow (a) will exhibit brain electrical activity consistent with less severe brain functional impairment observable by an evaluation of the functions on the flow chart.
Time frame: within 24 hours of injury
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
...and 1 more locations