Wearable Sensor and Digital Technologies for Quantitative Assessment and Remote Monitoring of Symptoms in Myasthenia Gravis

用于定量评估和远程监测重症肌无力症状的可穿戴传感器和数字技术

• 批准号: 10757163
• 负责人: Amanda Guidon
• 金额: $ 4.07万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-03 至 2023-07-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10757163
• 关键词: Activities of Daily Living; Autoimmune; Biological Markers; Caring; Characteristics; Chronic; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Complement; Consumption; Development; Digital biomarker; Disease; Dysarthria; Face; Funding; General Hospitals; Health Insurance Portability and Accountability Act; Health Services Accessibility; Health Technology; Immunosuppressive Agents; Marketing; Massachusetts; Mediation; Methods; Movement; Muscle Weakness; Myasthenia Gravis; Neuromuscular Diseases; Onset of illness; Outcome; Patients; Persons; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Ptosis; Public Health; Quality of Care; Quality of life; Rare Diseases; Recording of previous events; Research; Secure; Site; Small Business Innovation Research Grant; Specialist; Speech; Symptoms; Technology; Telemedicine; Testing; Time; Titrations; Travel; United States National Institutes of Health; biomarker discovery; clinical phenotype; clinical trial readiness; common symptom; cost; data exchange; digital technology; effective therapy; efficacy evaluation; improved; individual response; insight; mHealth; mobile application; motor symptom; nervous system disorder; personalized medicine; remote assessment; remote monitoring; wearable device; wearable sensor technology; web site

PROJECT SUMMARY 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.

项目概要 重症肌无力（MG）是一种慢性自身免疫性神经肌肉疾病，其特征是肌肉波动 虚弱和干扰日常生活活动并对生活质量产生负面影响的症状。 MG 目前，症状是通过神经肌肉检查人员仔细询问病史和进行体格检查来亲自评估的。 疾病专家。这种临床评估既耗时又主观，只能提供一个快照 患者的疾病，并且不能充分反映波动性虚弱和症状的范围。 2019 年，NIH 资助了一个名为 MGNet 的罕见疾病临床研究联盟。该联盟专注于 改进临床表型的表征、生物标志物的发现以及推进临床试验准备 对于 MG，这将促进更有效和个性化治疗的开发。在这条快车道上 SBIR 项目 BioSensics 将与马萨诸塞州综合医院合作 - 联盟的主要站点之一 为大约 200 名 MG 患者提供护理的 MGNet - 开发和验证可穿戴传感器 解决方案 (MGWear) 用于持续远程监测 MG 患者的运动症状和功能 一个安全的移动应用程序（MG 应用程序），用于自动评估语音和面部特征（即 构音障碍和上睑下垂），这是 MG 最常见的症状。移动应用程序还将启用 将数据从可穿戴设备传输到 BioSensics 符合 HIPAA 标准的后端云（称为 BioDigit） 可以通过安全网站访问的云。 该项目将补充 MGNet 的成果和生物标志物研究，并代表重要的公共卫生 BioSensics 的需求和市场机会。所提出的解决方案技术的关键应用和市场 是药物临床试验。可穿戴传感器和数字技术（例如此处提出的技术） 将使药物开发人员能够更快地进行测试和迭代，为评估疗效提供有价值的新方法。 BioSensics 是为临床试验提供可穿戴传感器和数字技术的领导者。该项目将 通过提供移动健康 (mHealth) 技术，显着拓宽 BioSensics 的产品和能力 远程监测重症肌无力和其他神经系统疾病的运动症状、言语和上睑下垂。临床上， 所提出的解决方案可用于预测个体对免疫抑制药物的反应并改善 中介滴定。此类解决方案可以检测基于运动和数字的细微变化 生物标志物并提供对临床疾病发作阶段的深入了解。此外，越来越多地使用 为了扩大远程医疗的覆盖范围并可能降低高质量护理的成本，需要进行远程评估 策略。美国 20% 的州（50 个州中的 10 个州）没有针对重症肌无力的专门护理。出行时间、距离 即使在拥有公认的重症肌无力专家的州，费用也可能会限制患者获得专家护理的机会。拟议的 远程监控技术有可能减少 MG 患者获得优质护理的障碍。

项目成果

Digital assessment of speech in Huntington disease.

亨廷顿病言语的数字评估。

• 发表时间: 2024
• 作者: Nunes, Adonay S;Pawlik, Meghan;Mishra, Ram Kinker;Waddell, Emma;Coffey, Madeleine;Tarolli, Christopher G;Schneider, Ruth B;Dorsey, E Ray;Vaziri, Ashkan;Adams, Jamie L
• 通讯作者: Adams, Jamie L