New Studies Suggest the Potential of BrainScope Technology to be an Objective Indicator of Brain Injury, Recovery and Readiness to Return to Sports
BETHESDA, MD. May 16th, 2012 – BrainScope® Company, Inc. today announced the findings of two publications from clinical studies conducted over three years in collegiate and high school football players who sustained concussions. These findings suggest that BrainScope's technology may be able to detect the existence of traumatic brain injury including concussion (TBI), categorize the severity of TBI, and provide an indication of the length of time needed for recovery and return to play. Currently in development, BrainScope's proprietary technology records brain electrical activity with a hand-held, easy-to-use device, and utilizes advanced algorithms that quantify and characterize features of brain electrical activity associated with TBI.
These studies included 65 football players who experienced concussions and were tested using BrainScope's technology within 24 hours of injury, and then retested at 8 and 45 days post injury. Commonly used clinical assessments and computerized neurocognitive tests were also conducted in each case. The athletes were divided into mild or moderate concussion categories based on the severity of neurocognitive and symptom assessments, the results of which were blinded to participants. More than 1,000 BrainScope assessments were performed over the three years of sports studies.
The first study, "Measuring Brain Electrical Activity to Track Recovery from Sport-Related Concussion," published in the peer-reviewed journal Brain Injury, extends the results of previously published research using BrainScope technology and shows that abnormal brain function at injury persists beyond the point of recovery defined by clinically observed symptoms.
The second study, "Time Course of Clinical and Electrophysiological Recovery Following Sport-Related Concussion," published in the peer-reviewed Journal of Head Trauma Rehabilitation, suggests that BrainScope's technology could be an objective indicator of injury, recovery and readiness to return to play in athletes who sustain sports-related concussions. The study included a "TBI-Index" of brain dysfunction, an algorithmically-derived quantitative output from the BrainScope device, which reflected whether the injury was mild or moderate in severity. This index was found to be significantly higher in the moderate versus mild concussion group at all time points, whereas increased severity of clinical symptoms and decreased neurocognitive test performance were only observed at the time of injury. Most importantly, at the time of injury, categorization by the BrainScope TBI-Index was the only measure that was significantly associated with the length of time taken before return to play, with approximately 80% of those categorized by the BrainScope TBI-Index as a mild concussion returning to play symptom-free in less than 14 days, and approximately 80% of those categorized at the time of injury as a moderate concussion returning to play in more than 14 days.
“These studies add to the growing body of scientific literature on the value of rapid, objective methods for assessment of acute concussion that inform the decision making process about an athlete’s readiness to return to play after a sport-related concussion,�? said Michael McCrea, Ph.D., Director of Brain Injury Research, Medical College of Wisconsin, who was the lead investigator.
These studies extend and replicate findings from BrainScope’s first year of football studies that were published in the peer reviewed Journal of Head Trauma Rehabilitation (2010), which suggested that brain function recovery after sport-related concussions may extend well beyond the time course of clinical recovery. These newly published studies further suggest that an index of brain dysfunction may be used effectively in the acute phase of evaluating a potential head injury.
“The fact that BrainScope’s TBI-Index significantly predicted the clinical outcome at the time of injury suggests that it could be an important adjunct to the acute evaluation of concussive injury,�? said the lead author, Leslie S. Prichep, Ph.D., Director of the Brain Research Laboratories, NYU School of Medicine.
The Journal of Head Trauma Rehabilitation publication can be found athttp://journals.lww.com/headtraumarehab/Abstract/publishahead/Time_Course_of_Clinical_and_Electrophysiological.99912.aspx and the Brain Injury publication can be found at http://informahealthcare.com/doi/abs/10.3109/02699052.2011.608216.
“These publications provide further compelling evidence about the potential for our technology to help assess both the existence and extent of concussion shortly after injury,�? said Michael Singer, President and CEO of BrainScope. “We are pleased to add these studies conducted in the sports environment to previously published studies which demonstrated the feasibility of using the BrainScope device in the Emergency Department. Whether in the locker room, the emergency room, or in the military environment, there is a true need for an objective assessment tool for TBI beyond what currently exists. We are encouraged by the results of these studies and look forward to our clinical validation trials.�?
In December 2011, BrainScope announced that it had been awarded a $7.5 million contract by the United States Department of Defense for the "Assessment of Head Injury in the Emergency Department: Clinical Validation of the BrainScope Ahead® Technology." In May 2011, BrainScope reached concurrence with the U.S. Food and Drug Administration (FDA) on the key study design elements for clinical validation of the Ahead® M-100 medical device.
BrainScope devices under development for assessment of traumatically-induced head injury and concussions are for investigational use only and have not been submitted for FDA review.
Backed by Revolution LLC (created by AOL co-founder Steve Case), Brain Trust Accelerator Fund, Maryland Venture Fund, Alafi Capital, Draper Fisher Jurvetson, Portage Ventures, and ZG Ventures, BrainScope is a medical neurotechnology company that is developing a new generation of hand-held, easy-to-use, non-invasive instruments, designed to aid medical professionals in rapidly and objectively assessing brain function. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of brainwave recordings with advanced developments in digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors. BrainScope's initial focus is on traumatic brain injury (TBI) and its milder presentation which is commonly referred to as "concussion". BrainScope's unique device is being developed to meet a long-standing clinical need for improved early identification, staging and triage for head-injured patients. BrainScope devices under development for assessment of traumatically-induced head injury and concussions are for investigational use only and have not been submitted to FDA for premarket review. For more information, please visit www.brainscope.com.