BrainScope Surpasses Primary Endpoints in Multi-Year Department of Defense-Funded Validation Study for New Concussion Assessment Capability
BETHESDA, MD. July 25, 2019 - 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.
About BrainScope
BrainScope’s mission is to revolutionize the rapid and objective assessment of brain-related conditions, starting with concussion and mild traumatic brain injury, utilizing multiple integrated assessment capabilities, artificial intelligence (AI) and digitization. The company is a two-time winner of the GE-NFL Head Health Challenge and has received two nominations for the Prix Galien Best Medical Technology (in 2017 and 2018), regarded as the equivalent of the Nobel Prize for medical devices. The company’s initial product, BrainScope One, is now being used in numerous military divisions and in health systems, urgent care centers and universities. For more information, please visit www.brainscope.com.
This work was completed under Contract No. W911QY-14-C-0098 entitled “Objective Brain Function Assessment of mTBI from Initial Injury to Rehabilitation and Treatment Optimization" by the U.S. Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the US Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division.
