ETSense: Adaptive Portable Essential Tremor Monitor

描述（由申请人提供）：目的是设计、实施和临床评估“ETSense”，一种自适应、紧凑、便携式特发性震颤（ET）监测仪，用于优化治疗干预。ET的主要特征是肢体的姿势性和运动性（动作）震颤，其通过各种主观震颤评定量表进行评定。这些量表都在离散的时间点提供离散的主观症状评级，需要临床医生对患者进行目视评估，并且无法捕获全天响应于干预而发生的复杂波动。在日常活动中持续客观地捕获ET症状，并使用自适应算法对震颤类型和严重程度进行分类，将有助于临床医生更好地滴定治疗，以最大限度地减少症状波动，并将护理扩展到农村和服务不足的人群。第一阶段ETSense工作成功地使用了从放置在ET受试者手指上的传感器单元记录的运动学数据，以区分震颤与日常活动相关的自主运动，并客观地量化震颤严重程度，评分与临床医生的定性评级高度相关，为连续ET评估提供了标准化平台。震颤量化算法被外推到非标准化任务，这表明在日常生活活动期间全天连续评定震颤是可行的。所提出的系统的三个主要创新包括：1）用于在ADL期间连续监测的紧凑、便携、用户穿戴式设备，2）用于连续分类震颤类型和频率严重性的智能、自适应算法，以及3）对症状反应报告的基于网络的访问。临床可部署系统将包含在一个轻便的手指佩戴式外壳中，以便患者在家中或公共场所执行日常任务时连续佩戴。按钮日志将允许患者指示何时服用药物。所有数据将存储在内存中，用于后续分析和报告生成，详细说明治疗干预后的症状波动。第一阶段开发的自适应算法将进一步优化，以考虑可能产生震颤假阳性或掩盖运动性震颤信号的自主运动。系统将根据检测到的任何自主运动在评分算法（即休息、运动）之间切换。数据收集完成后，临床医生将使用网络界面查看患者报告。这些报告将详细介绍震颤的类型、严重程度和波动，以及何时服用药物，以帮助临床医生优化现有的治疗干预措施或研究和开发新的治疗方案。我们假设，商业ETSense系统将1）在日常生活活动期间全天连续量化震颤严重程度，2）通过更好和/或更快的药物优化改善患者结局，3）通过减少办公室访问降低医疗保健成本，以及4）通过高分辨率连续家庭监测促进新型治疗干预措施的测试和验证。 公共卫生相关性：特发性震颤，主要特征是运动期间的震颤，影响美国40岁以上人群的约4%，但确切的患病率可能要高得多，因为高达90%的ET患者不寻求治疗。拟议的ETSense自适应便携式特发性震颤监测仪将在患者进行典型活动时对震颤类型进行分类，并对震颤严重程度进行持续评估，这将有助于临床医生更好地制定治疗方案，并有助于开发新的治疗干预措施。

DESCRIPTION (provided by applicant): The objective is to design, implement, and clinically assess ETSense", an adaptive, compact, portable essential tremor (ET) monitor for optimizing therapeutic interventions. ET is characterized primarily by postural and kinetic (action) tremors of the limbs, which are rated by various subjective tremor rating scales. These scales all provide a discrete, subjective symptom rating at a discrete point in time, require a clinician to visually assess the patient, and cannot capture complex fluctuations that occur throughout the day in response to interventions. Objectively capturing ET symptoms continuously during daily activities and using adaptive algorithms to both classify tremor types and severity will help clinicians better titrate therapy to minimize symptom fluctuations and expand care to rural and underserved populations. The Phase I ETSense effort successfully used kinematic data recorded from a sensor unit placed on the finger of subjects with ET to discriminate tremor from voluntary motion associated with daily activities and objectively quantified tremor severity with scores highly correlated with clinicians' qualitative ratings, providing a standardized platform for continuous ET assessment. Tremor quantification algorithms were extrapolated to non-standardized tasks, suggesting that it is feasible to rate tremor continuously throughout the day during activities of daily living. The three primary innovations of the proposed system include: 1) a compact, portable, user-worn device for continuous monitoring during ADLs, 2) intelligent, adaptive algorithms to continuously classify tremor type and rate severity, and 3) web-based access to symptom response reports. The clinically deployable system will be contained in a lightweight, finger-worn housing for continuous wear while patients perform everyday tasks at home or in public. A push button diary will allow the patient to indicate when medication is taken. All data will be stored in memory for subsequent analysis and report generation detailing symptom fluctuations in response to therapeutic interventions. Adaptive algorithms developed in Phase I will be further optimized to account for voluntary motion that can create tremor false positives or mask over kinematic tremor signals. The system will shift between scoring algorithms (i.e. rest, kinetic) based on any voluntary motion detected. After data collection is complete, clinicians will use a web-interface to view patient reports. These reports will detail tremor type, severity, and fluctuations, as well as when medication was taken to aid clinicians in optimizing existing therapeutic interventions or in the research and development of novel treatment protocols. We hypothesize that the commercial ETSense system will 1) continuously quantify tremor severity throughout the day during activities of daily living, 2) improve patient outcomes with better and/or faster medication optimization, 3) decrease healthcare costs by reducing office visits, and 4) enable the testing and validation of novel therapeutic interventions, facilitated by high-resolution continuous home monitoring. PUBLIC HEALTH RELEVANCE: Essential tremor, characterized primarily by tremor during movement, affects approximately 4% of the population over age 40 in the United States, though exact prevalence may be much higher since up to 90% of ET patients do not seek treatment. The proposed ETSense adaptive, portable essential tremor monitor will classify tremor type and rate tremor severity continuously throughout the day while a patient performs typical activities, which should help clinicians to better prescribe treatment and aid in the development of novel therapeutic interventions.