Publication demonstrates high accuracy for identification of acute stroke


BrainScope Company has announced the publication of an independent study that demonstrated the potential clinical utility of its traumatic brain injury 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 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, USA.

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 traumatic brain injury algorithms are based on advanced signal processing of brain electrical activity for classification of traumatic brain injury, developed on a large population of head injured patients with mild presentation to the Emergency Department. Using a BrainScope traumatic brain injury algorithm on an independent cohort of stroke patients, this study prospectively demonstrated high sensitivity (92%) for the identification of acute stroke (haemorrhagic and ischaemic).

“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,” states Edward Michelson, 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; University Hospitals Case Medical Center, Cleveland; William Beaumont Medical Center, Royal Oak; and Washington University, St. Louis, all USA.

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 ischaemic stroke patients who were initially negative for stroke on computerised tomography of the head (CT-) but later found to be positive on magnetic resonance imaging (MRI+). Eighty per cent of these CT-/MRI+ ischaemic strokes were correctly identified as positive using the BrainScope traumatic brain injury 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 ischaemic 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 traumatic brain injury 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,” states Leslie Prichep, director of the Quantitative Neurophysiological Brain Research Laboratories and Professor of Psychiatry at the NYU School of Medicine, USA.

“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,” says Michael Singer, president and chief executive officer 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 utilising BrainScope’s technology have been published through 15 articles in leading peer-reviewed brain injury and emergency medicine journals such as Journal of NeurotraumaBrain InjuryAcademic Emergency Medicine, The Journal of Head Trauma Rehabilitation and The American Journal of Emergency Medicine.

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