Study of FDA-cleared Concussion Index Evaluates Student Athletes from 10 U.S. Universities and High Schools at Time of Injury, Return to Play, and 45 Days Later
BETHESDA, Md., Feb. 16, 2021 /PRNewswire/ -- JAMA Network Open has published "Validation of a Machine Learning Brain Electrical Activity-Based Index to Aid in Diagnosing Concussion Among Athletes," a ground-breaking study on the accuracy of the BrainScope FDA-cleared biomarker, the Concussion Index, to indicate the likelihood and severity of concussive brain injury and to aid in evaluating an athlete's readiness to return to play.
"What this shows us is that for the first time we have a point of care and objective marker that can rapidly identify the likelihood of concussive injury and can be used to follow patients from baseline through recovery," said lead author Dr. Jeffrey Bazarian, Department of Emergency Medicine, University of Rochester School of Medicine. "With its demonstrated accuracy and ease of use in the athletic environment, the Concussion Index has great potential to be incorporated into existing standard assessments of concussion to aid in objective clinical diagnosis and in determination of readiness to return to play."
In the study, male and female (age 13-25 years) athletes with concussion and athlete "controls" (without concussion) were assessed through a variety of methods, including EEG, cognitive testing and symptom inventories within 72 hours of the injury, when they returned to play, and 45 days after they returned to play. Specific variables from the multi-modal assessment were used to generate a Concussion Index at each time point, with EEG having the largest contribution.
The study was conducted between 2017 to 2019 with referrals from 49 high schools, colleges, and concussion clinics in the US. Of the 580 eligible participants in the analysis, 207 had concussion and 373 were control athletes without concussion, and a total of 1318 evaluations, including follow-ups, were included in the analyses. The Concussion Index had a sensitivity of 86%, specificity of 71%, and negative predictive value of 90%. These results support the high accuracy of the Concussion Index in the identification of the likelihood of concussion, with performance above that reported in the literature for concussion assessment tools, which are largely subjective and show poor replicability. The study can be accessed here.
"The results of this study are an independent demonstration of the power and reliability of BrainScope's Concussion Index –– as an objective marker in the clinical assessment of concussions at the time of injury and as a reliable indicator of change over time," said Dr. Leslie Prichep, Chief Scientific Officer of BrainScope. "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 is still developing."
The Concussion Index can be used for baselining (particularly with athletes and military recruits), at the time of injury, and to aid in decision-making on readiness to return to activity or duty. The addition of BrainScope's AI-derived Concussion Index, which received FDA clearance in late 2019, will complement the previously FDA cleared triage algorithms for assessing the likelihood of brain bleeds (99% sensitivity) and assessing the severity of functional impairment already on the device. The assessment takes less than 20 minutes from prep to results. The hand-held BrainScope device and disposable headsets are available today for sale through the company and must be used with a physician's order. The company is currently taking orders on the enhanced BrainScope device and expects the first customer placements and trainings to begin in March.
This material is based upon work supported by the US Army Contracting Command, Aberdeen Proving Ground, Natick Contracting Division, under Contract No. W911QY-14-C-0098. 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. This work was further supported by an award received as a Grand Prize Winner of the GE-NFL Head Health Challenge to advance the development of technologies that can detect early-stage mild traumatic brain injuries and improve brain protection.
About BrainScope Company, Inc.
BrainScope is a medical neurotechnology company that is improving brain health by providing objective, diagnostic insights that enable better patient care. BrainScope is leading the way in the rapid and objective assessment of brain-related conditions, starting with mild traumatic brain injury (mTBI), utilizing multiple integrated assessment capabilities, artificial intelligence (AI), and digitization. The company's technology supports the American College of Emergency Physicians (ACEP) Choosing Wisely® campaign to avoid CT scans of the head in emergency department patients with minor head injury. BrainScope's innovative EEG-based, AI-driven platform empowers physicians to quickly make accurate head injury assessments, addressing the full spectrum of traumatic brain injuries from structural (brain bleed) to functional (concussion) injuries, providing for the first time a full picture of the injury, and doing so in less time and without radiation. For more information, please visit www.brainscope.com.
Cherie Lucier, BrainScope Company Inc.
VP Brand Experience
SOURCE BrainScope Company, Inc.