A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.
The objective of this study is to validate the clinical utility of the BrainScope technology for the acute identification of structural brain injuries in a TBI population presenting to the ED with mild symptoms, following closed head injury.
Study Type
OBSERVATIONAL
Enrollment
981
A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.
Hartford Hospital
Hartford, Connecticut, United States
Emory University- Grady Hospital
Atlanta, Georgia, United States
R Cowley Shock Trauma Hospital
Baltimore, Maryland, United States
The primary objective of this study is to validate the clinical utility of the BrainScope Ahead 300 device for the acute identification of structural brain injuries in the TBI population, following closed head injury.
The co-primary endpoints for this study are the sensitivity/specificity pair for CT+ identified by the Ahead 300 algorithm classification.
Time frame: 30 days
To demonstrate the utility of the EEG normality indicator (NI) score from a given subject presented as a percentile of the normal population and an indicator score.
Time frame: 30 days
To evaluate the utility of creating a three-tier system for CT+ (CT-, Equivocal Zone (require close observation), and CT+).
Time frame: 30 days
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
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
UT-Houston Health Science Center
Houston, Texas, United States
...and 1 more locations