Study Using BrainScope’s Brain Function Index Suggests Compelling Utility as Concussion Biomarker

BrainScope Company Inc. has announced the results of a study spanning more than six years demonstrating that sports-related concussions can be objectively assessed using BrainScope’s proprietary electroencephalography (EEG) based Brain Function Index (BFI).

Published in Journal of Head Trauma Rehabilitation, the study entitled “The Use of an Electrophysiological Brain Function Index in the Evaluation of Concussed Athletes” was conducted at 14 colleges and high schools, and funded in part through an award received under the NFL-GE Head Health Challenge I. In the study, 354 male contact sports athletes, 110 of whom sustained a concussion, were evaluated with results demonstrating that concussive injury significantly affected brain function, which was reflected in the BFI of the concussed athletes.
 
BrainScope’s BFI, derived from characteristics of brain electrical activity that most closely reflect the physiology of concussion, was found to show highly significant differences between concussed athletes at the time of injury compared with non-injured athletes. Furthermore, at both pre-season baseline and 45 days following the injury, concussed athletes and the non-injured control group exhibited equivalent BFI scores, suggesting that the BFI can potentially provide an objective marker of concussive injury and recovery over time.
 
The Centers for Disease Control and Prevention estimates there are up to 3.8 million sports and recreation related concussions in the United States each year. Further, a 2014 JAMA publication reported head injury related hospital emergency room (ER) visits have increased at eight times the rate of overall ER visits. The increase most likely reflects the significant public awareness and media focus on both the short and long term consequences of concussion. There is currently no gold standard for concussion, so current evaluation and diagnosis has relied on subjective reporting of symptoms.
 
“The results of this study are important in demonstrating the potential role for an EEG-based biomarker to assist with more objective evaluation of concussed individuals. It can advance our assessment of these injured athletes well beyond the current symptom based assessments,” said first author M. Alison Brooks, M.D., MPH, associate director of sport concussion and nutrition research at the University of Wisconsin Division of Intercollegiate Athletics.
 
Recent studies show that an early initial diagnosis of concussion is related to better long term outcomes and earlier recovery, stressing the need for more objective markers. “The Brain Function Index integrated into the clinical assessment of injured athletes can provide an objective measure of brain function. It contributes to a clinician’s early diagnosis of concussion and more informed immediate decisions about return to play,” said Leslie S. Prichep, chief scientific officer of BrainScope and a professor at New York University School of Medicine.
 
“The substantially increased awareness of concussions nationwide by parents, universities and sports organizations calls for more objective and comprehensive capabilities which can be accessed right at the point of care,” stated Michael Singer, CEO of BrainScope. “This multi-year study shows that BrainScope’s BFI can provide important quantitative information about the status of brain function after head injury. This is an important finding particularly when concussions can contribute to debilitating and lingering post-concussion symptoms.”
 
The company is currently selling the U.S. Food and Drug Administration (FDA)-cleared BrainScope One, which includes its proprietary BFI for use in mildly presenting closed head injured patients between the ages of 18 and 85 years and evaluated within three days of injury. In the 720 patient BrainScope One prospective validation trial which led to its September 2016 FDA clearance, the BFI was shown to have a significant relationship with severity of functional impairment in mild head injured patients. This newly published study, conducted using BrainScope’s Investigational devices and within a population that extended below 18 years of age, had longitudinal findings beyond the utility of the BrainScope One product cleared by the FDA. The results of this study suggest the potential future use of the BFI for longer term assessments and to track recovery from concussion.

“We are pleased about the recent commercial launch of BrainScope One to aid in early identification, evaluation and near-term return-to-play decisions for college and professional athletes, and excited about the potential future use of the BFI to track recovery from concussion over the long term,” said Singer.
 
BrainScope is developing a new generation of handheld, easy-to-use, non-invasive devices designed to aid medical professionals in rapidly and objectively assessing various neurological conditions, beginning with traumatic brain injury (TBI), including concussion. The company’s first product introduced in 2017, BrainScope One, uses EEG-based technology that is non-invasive for mildly presenting patients 18-85 years old and within three days after head injury. BrainScope One measures and interprets brain electrical activity and a patient’s neurocognitive function, creating a panel of objective data to help physicians make their clinical diagnosis. BrainScope’s technology platform integrates databases of thousands of brainwave recordings with advanced digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors, which are all covered by an extensive intellectual property portfolio of over 100 issued and pending patents. BrainScope has received four FDA clearances and ISO 13485:2003 certification. BrainScope has partnered with the U.S. Department of Defense for the development of its TBI assessment technology, and was named both an original recipient and final awardee of the GE-NFL Head Health Challenge I. BrainScope has also received significant funding from private investors to accelerate its development efforts, with backing from Revolution (created by AOL co-founder Steve Case), ZG Ventures, Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital.

Reference
M. Alison Brooks, MD; Jeffrey J. Bazarian, MD; Leslie S. Prichep, PhD; Samanwoy Ghosh Dastidar, PhD; Thomas M. Talavage, PhD; William Barr, PhD “The Use of an Electrophysiological Brain Function Index in the Evaluation of Concussed Athletes” Journal of Head Trauma Rehabilitation, May 17, 2017, doi:10.1097/HTR.0000000000000328.