BrainScope Announces Publication of Independent, Prospective Validation Study Demonstrating High Accuracy For Identification of Traumatic Intracranial Hematomas
Study Suggests the Potential of BrainScope Technology to be an Important Adjunct to
Assessment of Traumatic Brain Injury in the Emergency Department
BETHESDA, MD. January 6th, 2014 – BrainScope® Company, Inc. today announced the publication of an independent study that demonstrated the potential clinical utility of its technology to identify traumatic intracranial hematomas in the hospital Emergency Department (ED). The results of this study, “Use of Brain Electrical Activity for the Identification of Hematomas in Mild Traumatic Brain Injury" were published in the December 15, 2013 issue of the peer-reviewed Journal of Neurotrauma.
BrainScope’s proprietary technology records brain electrical activity with a handheld, rapid, easy-to-use, non-invasive and non-radiation emitting device. The technology utilizes advanced classification algorithms that quantify and characterize features of brain electrical activity associated with traumatic brain injury (TBI).
In this study, ten minutes of brain electrical activity was recorded in 38 adult patients with traumatic hematomas (CT scan positive, CT+) and 38 mild head-injured matched controls (CT scan negative, CT-). The volume of blood and distance from recording electrodes were measured by blinded independent experts. A classification algorithm independently developed by BrainScope (the “TBI-index") was used to identify the probability of a traumatic CT+ event.
The study reported a sensitivity of 100% to hematomas, independent of type of hematoma, blood volume, or distance of the bleed from the recording electrodes on the forehead. Because of the life-threatening risk of undetected hematomas, specificity was permitted to be lower (66%) in exchange for extremely high sensitivity. Importantly, this study demonstrated that the distance and volume restrictions noted with other commercially available methods for detecting traumatic intracranial hematomas were not limitations of BrainScope’s technology. These results suggest potential enhanced clinical utility of the BrainScope TBI-Index as an important adjunct to acute assessment and triage of head injury.
“Many times patients, like the ones in this study, present with mild symptoms of TBI, and upon clinical evaluation it is not always clear whether the patient might have a more severe injury with bleeding in the brain. The ability to detect the presence of such injuries non-invasively and without radiation could result in a paradigm shift in the way emergency medicine for TBI is currently practiced," said Michael Singer, President and CEO of BrainScope. “This peer-reviewed publication provides further compelling evidence about the potential for our technology to help assess the existence of brain injuries shortly after injury. Whether in the military or civilian hospital emergency department, there is a true need for an objective assessment tool for TBI beyond what currently exists. We are highly encouraged by the results of this study."
BrainScope previously announced the findings of publications from clinical studies conducted over several years in collegiate and high school football players who sustained concussions. These findings suggested that BrainScope’s technology may be able to detect the existence of TBI (including concussion), categorize the severity of TBI, and provide an indication of the length of time needed for recovery and return to play. Since 2010, results from clinical studies utilizing BrainScope’s technology have been published in leading peer-reviewed neurology and emergency medicine journals such as Brain Injury, The Journal of Head Trauma Rehabilitation and The American Journal of Emergency Medicine.
BrainScope devices under development for assessment of traumatically-induced head injury are for investigational use only.
The full citation for this article is: HanleyDaniel F., ChabotRobert, MouldW. Andrew, MorganTimothy, NaunheimRosanne, ShethKevin N., ChiangWilliam, and PrichepLeslie S.. Journal of Neurotrauma. December 15, 2013, 30(24): 2051-2056. doi:10.1089/neu.2013.3062. It can be found at http://online.liebertpub.com/doi/abs/10.1089/neu.2013.3062.
About BrainScope®
Backed by Revolution (created by AOL co-founder Steve Case), Shaman Ventures, ZG Ventures, Maryland Venture Fund, Brain Trust Accelerator Fund, and Difference Capital, 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 TBI. BrainScope devices in development are based on a proprietary technology platform, which integrates databases of brainwave recordings with advanced digital signal processing, sophisticated algorithms, miniaturized hardware and disposable headset sensors. BrainScope's unique devices are being created to meet a long-standing clinical need for improved early identification, staging and triage of head injured patients. BrainScope devices under development for assessment of traumatically-induced head injury and concussion are for investigational use only. For more information, please visit www.brainscope.com.
