BrainScope Surpasses Primary Endpoints in Multi-Year Department of Defense-Funded Validation Study for New Concussion Assessment Capability
BrainScope announced today that it has successfully completed a nearly five year, $9.9 million U.S. Department of Defense research contract supporting the development and validation of an objective marker of the presence and severity of concussion. In a large blinded validation study, the system demonstrated its ability to help clinicians assess concussion at the time of injury, reflect severity of injury, and aid in their assessment of readiness to return to activity. BrainScope extended the work performed under this Department of Defense contract to include adolescents funded through private investment from BrainScope and a second award from the NFL-GE Head Health Challenge I.
Through the research contract, the BrainScope “Concussion Index', an EEG-based, multimodal marker for concussion, was developed and then validated in a blinded clinical study. All pre-specified performance targets were achieved or exceeded. These clinical studies were conducted from 2015 through 2019 at 52 clinical sites, and included nearly 1,700 patients and healthy controls with over 4,000 evaluations conducted at high schools, colleges and concussion clinics. The research also extended the target population from 18-25 years down to 13 years of age.
The primary aim of the blinded study was to validate the clinical utility of the Concussion Index for assessing the likelihood of concussion with both high sensitivity and specificity, in patients aged 13-25 who sustained a closed head injury. Additional endpoints supported the use of the Concussion Index as an important objective component of the clinical assessment of the severity of concussive injury, and in the evaluation of readiness to return to activity. “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. Importantly, the study targeted patients of high school and college age who are at great risk for both short and long term consequences of concussion, as the brain in still developing,' stated Dr. Leslie Prichep, Chief Scientific Officer of BrainScope and the Contract’s Principal Investigator. BrainScope CEO, Susan Hertzberg added, “We are thankful to the Department of Defense for our long-term collaborative relationship. 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 510(k) submission for this capability is currently under review by FDA.