Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease characterized by fluctuating muscle weakness and symptoms that interfere with activities of daily living and negatively impacts quality of life. MG symptoms are currently assessed in person through a careful history and physical exam by a neuromuscular disease expert. Such in-clinic assessments are time-consuming, subjective, only provide a snapshot of a patient's disease and do not adequately reflect the spectrum of fluctuating weakness and symptoms. In 2019, NIH funded a rare disease clinical research consortium called MGNet. The consortium is focused on improved characterization of clinical phenotypes, discovery of biomarkers, and advancing clinical trial readiness for MG, which would enhance the development of more effective and personalized treatments. In this Fast Track SBIR project, BioSensics will collaborate with Massachusetts General Hospital - one of the key Consortium sites for MGNet that provides care to approximately 200 MG patients - to develop and validate a wearable sensor solution (MGWear) for continuous remote monitoring of motor symptoms and function in MG patients and also a secure mobile application (MG app) for automatic assessment of speech and facial characteristics (i.e. dysarthria and ptosis), which are the most common symptoms of MG. The mobile application will also enable the transfer of data from the wearable device to BioSensics HIPAA-compliant backend cloud called BioDigit Cloud that can be accessed via a secure website. The project will complement outcome and biomarker research by MGNet and represent significant public health need and market opportunity for BioSensics. A key application and market for the proposed solution technology is pharmaceutical clinical trials. Wearable sensors and digital technologies like the technology proposed here will allow drug developers to test and iterate faster, providing a valuable new method for evaluating efficacy. BioSensics is a leader in providing wearable sensor and digital technologies for clinical trials. This project will significantly broaden BioSensics offerings and capabilities by providing mobile health (mHealth) technologies for remote monitoring of motor symptoms, speech and ptosis in MG and other neurological diseases. Clinically, the proposed solution can be used to predict an individual's response to immunosuppressive drugs and to improve mediation titration. Such solutions can enable detecting subtle changes in movement-based and digital biomarkers and provide insight into the phase of clinical disease onset. Additionally, the growing use of telemedicine to expand access and potentially reduce costs of high-quality care will require remote assessment strategies. 20% of states in the US (10 out of 50 states) have no specialized care for MG. Travel time, distance and cost may limit patients' access to expert care, even in states with identified MG specialists. The proposed remote monitoring technologies have potential to lessen barriers to quality care access for MG patients.
Public Health Relevance Statement: PROJECT NARRATIVE Myasthenia gravis (MG) symptoms are currently assessed in person through a history and physical exam by a neuromuscular disease expert. Such in-clinic assessments are time-consuming, subjective, only provide a snapshot of a patient's disease, and do not adequately reflect the spectrum of fluctuating weakness, which is a hallmark of MG. In this project, we will develop and validate MGWear, a wearable sensor solution for continuous remote monitoring of motor symptoms and function in MG patients, and also a secure mobile application (MG app) for automatic assessment of speech and facial characteristics (i.e., dysarthria and ptosis), which are the most common symptoms of MG.
Project Terms: Acoustics; Acoustic; Activities of Daily Living; Activities of everyday life; daily living functionality; functional ability; functional capacity; Age; ages; Algorithms; Ambulatory Care Facilities; Outpatient Clinics; Anxiety; Architecture; Engineering / Architecture; Attitude; Clinic Visits; Clinical Research; Clinical Study; Clinical Trials; Complement; Complement Proteins; Disease; Disorder; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Dysarthria; Dysarthosis; Face; faces; facial; Fatigue; Lack of Energy; Feedback; Health Services Accessibility; Access to Care; access to health services; access to services; access to treatment; accessibility to health services; availability of services; care access; health service access; health services availability; service availability; treatment access; Recording of previous events; History; General Hospitals; Immunosuppressive Agents; Immunosuppressants; Immunosuppressive drug; Immunosuppressive treatment; immune suppressive agent; immune suppressor; immunosuppressive substance; immunosuppressor; Interview; Massachusetts; Methods; Movement; body movement; Myasthenia Gravis; Persons; NIH; National Institutes of Health; United States National Institutes of Health; Neck; Nervous System Diseases; Neurologic Disorders; Neurological Disorders; neurological disease; nervous system disorder; myoneural disorder; neuromuscular degenerative disorder; neuromuscular disorder; Neuromuscular Diseases; On-Line Systems; online computer; web based; Online Systems; Patents; Legal patent; Patient Reported Measures; Patient Reported Outcomes; Patient Outcomes Assessments; Patients; Perception; Procidentia; Prolapse; Ptosis; Public Health; QOL; Quality of life; Questionnaires; Research; Risk; Software; Computer software; Speech; Technology; Testing; Time; Travel; Wrist; Data Security; Data awareness; information security; Specialist; Data Set; Dataset; Caring; Muscle Weakness; Muscular Weakness; Titrations; Telemedicine; base; sensor; improved; Site; Chronic; Clinical; Phase; Medical; Training; insight; Neurologist; Trust; Funding; disease onset; disorder onset; Onset of illness; Adopted; Severities; Clinic; Protocol; Protocols documentation; System; interest; Visit; experience; HIPAA; Kennedy Kassebaum Act; PL 104-191; PL104-191; Public Law 104-191; United States Health Insurance Portability and Accountability Act; Health Insurance Portability and Accountability Act; Orphan Disease; Rare Disorder; orphan disorder; Rare Diseases; Participant; Negotiating; Negotiation; Mediation; Reporting; Generalized Myasthenia Gravis; Ocular Myasthenia Gravis; Health Care Technology; Healthcare Technology; Health Technology; Modeling; QOC; Quality of Care; Pharmaceutical Agent; Pharmaceuticals; Pharmacological Substance; Pharmacologic Substance; telehealth; Symptoms; Data; Collection; Enrollment; enroll; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Characteristics; Text; Development; developmental; web site; website; Instruction; clinical phenotype; cost; digital; Clinical assessments; efficacy evaluation; efficacy analysis; efficacy assessment; efficacy examination; evaluate efficacy; examine efficacy; clinical research site; clinical site; Outcome; Consumption; usability; prototype; effective therapy; effective treatment; Biological Markers; bio-markers; biologic marker; biomarker; data exchange; data transfer; data transmission; Secure; Systems Development; Cloud Computing; Cloud Infrastructure; cloud computer; Algorithmic Analysis; Algorithmic Analyses; Analyses of Algorithms; Analysis of Algorithms; mHealth; m-Health; mobile health; mobile application; mobile app; mobile device application; personalized medicine; personalization of treatment; personalized therapy; personalized treatment; biomarker discovery; data access; motor symptom; common symptom; recruit; wearable sensor technology; body sensor; body worn sensor; wearable biosensor; wearable sensor; wearable system; wearable device; wearable electronics; wearable technology; individual response; individualized response; machine learning algorithm; machine learned algorithm; machine learning based algorithm; remote monitoring; clinical trial readiness; Autoimmune; deep learning model; deep learning based model; remote assessment; remote evaluation
