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

项目摘要 重症肌无力（MG）是一种慢性自身免疫性神经肌肉疾病，以肌肉波动为特征 影响日常生活活动并对生活质量产生负面影响的虚弱和症状。MG 目前，通过仔细的病史和神经肌肉检查来评估症状 疾病专家这样的诊所内评估是耗时的、主观的，仅提供患者的一个快照。 患者的疾病，并没有充分反映波动的弱点和症状的频谱。 2019年，NIH资助了一个名为MGNet的罕见病临床研究联盟。该财团专注于 改善临床表型的表征，发现生物标志物，并推进临床试验准备 这将促进更有效和个性化治疗的发展。在这条快速通道中 SBIR项目，BioSensics将与马萨诸塞州总医院合作，该医院是联盟的关键站点之一 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），用于连续远程监测MG患者的运动症状和功能， 用于自动评估语音和面部特征的安全移动的应用（MG app）（即， 构音障碍和上睑下垂），这是MG最常见的症状。移动的应用程序还将使 将数据从可穿戴设备传输到BioSensics符合HIPAA标准的后端云BioDigit 可以通过安全网站访问的云。 该项目将补充MGNet的结果和生物标志物研究，并代表重要的公共卫生 生物传感器的需求和市场机会。建议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像这里提出的技术这样的数字技术 将使药物开发人员能够更快地进行测试和验证，为评估疗效提供了一种有价值的新方法。 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 通过提供移动的健康（mHealth）技术， 远程监测MG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， 介导滴定这样的解决方案可以检测基于运动的和数字的运动中的细微变化。 生物标志物和提供洞察临床疾病发作的阶段。此外，越来越多地使用 为了扩大获得高质量护理机会并有可能降低其成本，远程医疗将需要进行远程评估 战略布局美国20%的州（50个州中的10个）没有MG的专门护理。旅行时间、距离 而且成本可能会限制患者获得专家护理的机会，即使是在拥有确定的MG专家的州。拟议 远程监测技术有可能减少MG患者获得优质护理的障碍。

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.