The EEG-based multimodal marker, called BrainScope Concussion Index, was evaluated in a blinded validation study conducted from 2015 to 2019 at 52 clinical sites.
While the $9.9m DoD contract required the enrolment of participants aged 18-25, BrainScope extended the research to include people aged 13-17.
The study involved approximately 1,700 patients and healthy controls, and more than 4,000 assessments at high schools, colleges, and concussion clinics.
It was designed to validate the clinical utility of BrainScope Concussion Index in evaluating the likelihood of concussion in patients who have had a closed head injury. The study aimed to demonstrate high sensitivity and specificity.
Other endpoints of the study included the use of the biomarker as an objective component for the clinical assessment of the concussion’s severity and the patient’s readiness to return to activity.
According to BrainScope, the solution was able to aid clinicians in assessing concussion at the time of injury, reflect the injury severity, and help in the evaluation of readiness to return to activity.
BrainScope CEO Susan Hertzberg said: “We are extremely pleased with the outcome of this study, demonstrating the promise of the Concussion Index as an objective marker in the clinical assessment of concussion.
“These important research outcomes bolster our prospects of bringing this important capability to both service members and civilians to help address the national concussion epidemic.”
The US Food and Drug Administration (FDA) is currently reviewing the company’s submission for 510(k) clearance of the concussion biomarker.
BrainScope’s portfolio includes a non-invasive, hand-held platform for point-of-care assessments of traumatic brain injury (TBI).