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A Practical and Accessible Measure of Brain Vital Signs: the Neurocatch® Platform

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WHITE PAPER A Practical and Accessible Measure of Brain Vital Signs: the NeuroCatch® Platform Dr. Ryan C.N. D’Arcy Natasha K.J. Campbell Dr. Bimal Lakhani Dr. Shaun Fickling March, 2021 NeuroCatch Inc. Version 2.0 Unit 202E, City Centre 1, 13737 96th Avenue NC-108 v2.0 Surrey, BC, Canada V3V 0C6 An Unmet Need for an Objective, Physiological Measurement of Brain Function AN UNMET NEED FOR cognitive function often rely on neuropsychological batteries of attention, AN OBJECTIVE, perception, memory, and executive PHYSIOLOGICAL function. Unfortunately, these assessments depend on a person’s ability to produce MEASUREMENT OF on-demand responses, which are restricted BRAIN FUNCTION by limitations in communication and motor movement.7–13 Many of these subjective measures, therefore, are susceptible to Brain disorders directly impact one in three extraneous influences and have inherent Canadians.1 Yet, healthcare lacks sensitive flaws. instruments to measure healthy brain function versus dysfunction to guide An important gap in healthcare currently treatment and monitor recovery. Current exists: an unmet medical need for a rapid, assessments for brain health and function objective, physiological measurement of rely heavily on subjective self-reports. brain function in clinical settings. In Typical examples include the Glasgow essence, a vital sign for brain function. Coma Scale (used to evaluate level of Potential brain vital sign measures do exist conscious awareness following brain and are used primarily in research 2,3 injury ) and the National Institute of settings.4,14 Event-related potentials (ERPs), Health Stroke Scale (used as a screening measured by means of electro- tool for initial stroke severity). However, encephalography (EEG), are well these indirect behavior-based tests are characterized in research literature15 as a reported to have misdiagnosis rates as high physiological measure of brain function, 4,5 as 43%, and results are often confounded but the transfer of this technology to by interrater variability and lack of clinical settings and the frontlines of 6 sensitivity to mild changes. Along the healthcare have been limited to date. same line, more comprehensive tests of © 2021 NeuroCatch Incorporated. All rights reserved. Page 2 of 19 Event-Related Potentials (ERPs) 2013 2015 2013 2014 Brain vital signs first 1995 HealthTech Connex The term "brain vital Development of the deployed to the First ERP clinical (HTC) founded by Dr. signs" first used by NeuroCatch® Mayo Clinic to study translational work Ryan D'Arcy and Kirk Dr. Ryan D'Arcy Platform begins concussions in ice Fisher hockey 2016 2017 Validation in healthy 2019 2018 participants and 2020 Preparation for the Health Canada Repeatability and initial scientific NeuroCatch® version regulatory approval medical device usability testing report for brain vital 1.1 released of NeuroCatch® licence is received completed signs published in begins Frontiers of Neuroscience Figure 1. Brain vital sign development progress Research & Development (R&D) into the clinical applications of ERPs dates back EVENT-RELATED more than 25 years. This work has been POTENTIALS (ERPs) supported by all major prestigious competitive funding agencies in Canada ERPs are very small voltages generated in (Canadian Institutes of Health Research, the brain as a response to specific stimulus Canada Foundation for Innovation, Mitacs, events, such as listening to an auditory Natural Sciences and Engineering Research tone or spoken word.16 These signals can Council, the National Research Council be recorded with EEG technology using etc.) and has included training of more than non-invasive scalp electrodes. Since the 250 highly qualified research personnel 1930’s, ERPs have been extensively studied (e.g., PhD, MD, and Masters, Post-doctoral, as indicators of brain function, from low- and early career researchers). The team has level sensory to higher-level cognitive been led by Dr. R. D’Arcy, PhD, PlEng who processing.15 In 2021, a PubMed search of holds a BC Leadership Chair in Medical “event related potentials” returned Technologies and is full tenured Professor 145,860 peer-reviewed publications dating in Clinical Neuroscience, Neuroimaging, back to 1946, with the first reported and Neurotechnology at Simon Fraser evoked response dating back to 193417 and University, University of British Columbia, nearly 4000 new published studies in the and Surrey Memorial Hospital. last year alone, representing a robust scientific foundation on which to commercialize this technology. Over the © 2021 NeuroCatch Incorporated. All rights reserved. Page 3 of 19 Measuring Brain Vital Signs past 25 years, our group has led the monitoring the health of various body development of clinical ERP applications.7– systems (e.g., by establishing baselines and 12,18–21 This work has focused on developing managing risk factors). However, no such rapid, automated approaches to record vital signs yet exist for the brain – arguably ERPs at an individual level. the most important organ of all. Why ERPs now? While familiar to many, the Using blood pressure as a model, it has untapped potential and economical been possible to “reverse engineer” a vital advantage of EEG has historically been sign framework using well-established restricted to specialized laboratory ERPs. The brain vital sign framework settings.14 Experimental studies were also compressed hours of laboratory testing to far too lengthy (i.e., hours), complex (i.e., a 6-minute test that automatically elicits, advanced and lengthy electrophysiological analyzes, and identifies three key ERP analyses), and intensive (expert dependent) responses along the continuum of to be clinically accessible. Recent information processing – from low-level engineering advances have brought the sensation to higher-cognition.24 Critical mainstream availability of portable EEG components of this framework include that systems to the forefront, catalyzing their the brain vital signs must be: increased awareness and use. At the same time, historical challenges around the 1) Well-validated and extensively complexity and variability of EEG data have characterized within the research been recently overcome by signal literature; processing and classification advances.22,23 2) EEG hardware platform independent; As a direct result, R&D over the past 3) Recorded reliably within healthy decade has enabled the development of a individuals across the lifespan; vital sign framework to manage brain 4) Easily communicated and accessible to health in a manner analogous to the clinical healthcare practitioners; application of vital signs for managing 5) Set against reference value ranges of heart health. typical response characteristics. The initial description of the brain vital MEASURING BRAIN signs framework achieved significant VITAL SIGNS impact in the highly accessed Frontiers of Neuroscience: the article was the #1 Routinely checking objective physiological highest attention scoring study from 2016- vital signs, such as heart rate and blood 2020. Previous evidence of impact for our pressure, is an essential part of clinical ERP work includes editorials and preventative healthcare and key to invited reviews (in Clinical Neurophysiology © 2021 NeuroCatch Incorporated. All rights reserved. Page 4 of 19 Brain Vital Signs and the NeuroCatch® Platform and International Journal of research centres across Canada and the Psychophysiology), and citations in seminal USA (currently research-only). The second sources and authoritative textbooks (e.g., generation of NeuroCatch® will roll out in Neuropsychological Assessment; Evoked 2021 with advances in hardware, software, Potentials on Answers.com; Event-related and analytics. The third generation will potentials: A methods handbook; and improve upon this model and is planned Psychophysiology: Human Behavioural and for 2023. HealthTech Connex oversees Physiological Response). With more than NeuroCatch Inc., with both companies 30 international, peer reviewed scientific being recognized through numerous papers published (empirical, invited reviews international awards, distinctions, and and editorials), including five papers media coverage. published in 2020,25–29 the medical literature for brain vital signs has become BRAIN VITAL SIGN well established. VALIDATION IN BRAIN VITAL SIGNS AND HEALTHY INDIVIDUALS THE NEUROCATCH® To begin developing brain vital signs, three PLATFORM highly validated30 ERPs were selected: the N100 (linked to auditory sensation), P300 The extensively published scientific studies (linked to basic attention), and the N400 that led to the translation of ERPs to a (linked to cognitive processing). These brain vital sign framework also create the ERPs were validated across large samples foundation for the NeuroCatch® Platform. of healthy individuals.18 To date, brain vital NeuroCatch® is designed to rapidly record sign data has been collected on thousands and analyze ERP responses using portable of individuals and, owing to the rapid test EEG devices and providing automated, time, evaluations of normative ranges, standardized and clinically intuitive results. reliability and validity have been relatively As a Health-Canada-approved Class II fast to develop and predicably consistent medical device (MDL 102616), with the existing literature. The N100, NeuroCatch® is underpinned by P300, and N400 are specifically elicited by international patents and trademarks, standard auditory tone and spoken word together with extensive technical and
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