Study Suggests the Potential of BrainScope’s Technology to be an Important Adjunct to Assessment of Acute Stroke in the Emergency Department
BETHESDA, MD. January 6, 2015 – BrainScope Company, Inc. today announced the publication of an independent study that demonstrated the potential clinical utility of its Traumatic Brain Injury (TBI) technology to identify acute stroke in the hospital Emergency Department setting. The results of this study, "Identification of Acute Stroke Using Quantified Brain Electrical Activity"? were published today in the peer-reviewed journal Academic Emergency Medicine authored by investigators from University Hospitals Case Medical Center, New York University School of Medicine, and The Johns Hopkins University School of Medicine.
In this publication, BrainScope’s handheld, rapid, easy-to-use, non-invasive, and non-radiation emitting investigational device was used to evaluate potential acute stroke patients in hospital Emergency Departments. BrainScope’s proprietary TBI algorithms are based on advanced signal processing of brain electrical activity for classification of TBI, developed on a large population of head injured patients with mild presentation to the Emergency Department. Using a BrainScope TBI algorithm on an independent cohort of stroke patients, this study prospectively demonstrated high sensitivity (92%) for the identification of acute stroke (hemorrhagic and ischemic).
"Every year, 15 million people worldwide suffer a stroke. Nearly six million die and another five million are left permanently disabled. Stroke is the second leading cause of disability, after dementia. Complicating rapid triage are conditions presenting which clinically mimic stroke. 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 stroke is currently practiced,"? stated Edward Michelson, MD, Associate Professor of Medicine and Emergency Medicine, Case Western Reserve University School of Medicine.
The study included 48 acute stroke patients presenting to hospital Emergency Departments participating in the study and a control group of patients presenting with stroke-like symptoms ("stroke mimics"?) but who did not experience a stroke. Study sites included: Bellevue Hospital Center, New York, NY; University Hospitals Case Medical Center, Cleveland, OH; William Beaumont Medical Center, Royal Oak, MI; and Washington University, St. Louis, MO.
Sensitivity to stroke was 92%, specificity to stroke mimics was 50% and Negative Predictive Value (NPV) was 94%. Of particular interest was a group of ischemic stroke patients who were initially negative for stroke on Computerized Tomography of the head (CT-) but later found to be positive on Magnetic Resonance Imaging (MRI+). 80% of these CT-/MRI+ ischemic strokes were correctly identified as positive using the BrainScope TBI algorithm at the time the CT scan result was negative. The ability of a classification algorithm based on brain electrical activity to detect CT normal patients who are having ischemic events may improve triage by increasing the number of treatment-eligible patients at a critical time in the care continuum. Considering that stroke-mimics routinely receive CT scans, the specificity of the TBI algorithm suggests it may aid in better allocation of resources and a decrease in unnecessary radiation exposure.
"Despite a small population and the use of a classification algorithm derived without the benefit of ‘training’ it on a population of stroke and stroke mimic patients, this data suggests the potential clinical utility of this technology as an adjunct to acute assessment of stroke,"? stated Dr. Leslie Prichep, Director of the Quantitative Neurophysiological Brain Research Laboratories and Professor of Psychiatry at the NYU School of Medicine.
"While we as a company have fully focused our development efforts on Traumatic Brain Injury and concussion, this peer-reviewed publication provides initial compelling evidence about the potential for our overall technology platform to assess the existence of stroke shortly after it occurs,"? said Michael Singer, President and CEO of BrainScope. "We are highly encouraged by the results of this study and will continue to look for opportunities to expand our capabilities in stroke, which is of course a substantial worldwide clinical need."? Results from independent clinical studies utilizing BrainScope’s technology have been published through 15 articles in leading peer-reviewed brain injury and emergency medicine journals such as Journal of Neurotrauma, Brain Injury, Academic Emergency Medicine, The Journal of Head Trauma Rehabilitation and The American Journal of Emergency Medicine. In November 2014, BrainScope announced that the United States Food and Drug Administration (FDA) cleared the company’s Ahead® 100 device through the de novo classification process. The Ahead® 100 uses a patient’s electroencephalograph (EEG) to provide an interpretation of the structural condition of the patient’s brain after head injury. It is indicated for use as an adjunct to standard clinical practice to aid in the evaluation of patients who are being considered for a CT scan, but should not be used as a substitute for a CT scan. It is to be used on patients who sustained a closed head injury within 24 hours, clinically present as a mild traumatic brain injury, and are between the ages of 18-80 years.
The full citation for this article is: Michelson, E.A., Hanley, D., Chabot, R., Prichep, L.S. Identification of acute stroke using quantified brain electrical activity. Academic Emergency Medicine. 2015; 22(1): 67-72. doi: 10.1111/acem.12561.
Backed by Revolution (created by AOL co-founder Steve Case), Shaman Ventures, ZG Ventures, State of 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 Traumatic Brain Injury. 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 holds 74 issued and pending patents related to its technology. BrainScope has been awarded over $27 million of Department of Defense research contracts for the development of its TBI assessment technology and has received significant funding from private investors to accelerate its development efforts. BrainScope devices under development, including the Ahead® 200 and 300 series for assessment of traumatically-induced head injury are for investigational use only. BrainScope devices under development for assessment of acute stroke are for investigational use only. For more information, please visit www.brainscope.com.