ETAware: Continuous monitoring of the functional impact of essential tremor

ETAware：持续监测特发性震颤的功能影响

基本信息

批准号：
10819790
负责人：
Rabie Fadil
金额：
$ 28.95万
依托单位：
GREAT LAKES NEUROTECHNOLOGIES
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-30 至 2024-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10819790
关键词：
Activities of Daily Living Affect Algorithms Alzheimer&apos s Disease Caring Clinic Visits Clinical Clinical Trials Clinical assessments Data Data Collection Decision Making Deep Brain Stimulation Development Device Approval Disease Disease Management Disparity population Drug Approval Processes Drug usage Dystonia Effectiveness Effectiveness of Interventions Essential Tremor Evaluation Fingers Focused Ultrasound Improve Access Individual Judgment Limb Tremors Living Wills Lower Extremity Magnetic Resonance Imaging Measurement Measures Medical Monitor Monitoring Clinical Trials Motion Movement Disorders Observational Study Operative Surgical Procedures Orthostatic Hypotension Outcome Outcome Measure Output Parkinson Disease Participant Patient Care Patients Performance Persons Pharmaceutical Preparations Phase Physical activity Primidone Process Propranolol Quality of life Questionnaires Refractory Research Research Personnel Rest Rural Population Sensitivity and Specificity Severities Stroke Symptoms System Technology Therapeutic Intervention Time Titrations Tremor Underserved Population Upper Extremity Validation Visual Walking Work clinical decision-making commercialization cost design effectiveness evaluation evidence base geographic disparity health care availability improved innovation kinematics machine learning model mobile application motion sensor novel therapeutics patient response sensor signal processing success symptomatic improvement treatment optimization wearable device

项目摘要

Summary The objective is to design and clinically assess ETAware, an adaptive, wearable system to monitor the impact of tremor on activities of daily living (ADL) for the evaluation and optimization of therapeutic interventions in patients with essential tremor (ET) as there is currently no technology that can assess the functional impact of tremor on ADL. ETAware will focus on ET, the most common movement disorder, affecting 10 million people in the US; however, commercially, the system will have applications for other conditions that hinder engagement in daily activities and affect quality of life. Currently, propranolol and primidone are the two main drugs used for treating essential tremor, while surgical interventions such as deep brain stimulation (DBS), and MRI-guided focused ultrasound (MgFUS) are warranted in medically refractory ET. Nevertheless, patients' responses to all forms of therapy can vary substantially, necessitating the sequential use of different drugs. To evaluate the effectiveness of interventions, it is critical to quantify both tremor severity and its impact on ADL in ET. Currently, to show clinical improvement, subjective questionnaires and rating scales are used. However, these questionnaires and rating scales are subject to clinical judgment and bias, only provide information at a discrete point in time, and cannot be utilized for daily continuous monitoring. ETAware will continuously monitor tremor severity AND the functional impact of tremor on ADL, which will help clinicians with therapy adjustments, help patients take control of their disease management, and improve research and clinical trials by providing an objective quality of life measure and minimizing the costs associated with clinic visits and the administration of questionnaires and rating scales. We have previously commercialized wearables and mobile apps that are currently used in drug clinical trials for monitoring upper limb tremor severity. However, the existing systems do not quantify lower limb tremor or give any information on the impact of tremor on ADL. The primary innovations of ETAware are 1) signal processing algorithms to analyze motion sensor data and provide continuous measurements of the functional impact of tremor on ADL, 2) a system for clinicians to optimize therapy, researchers to evaluate and develop new therapies, and patients to stay involved in their disease management. To demonstrate feasibility in Phase I, motion data will be collected from 20 patients with essential tremor while they are performing TETRAS-based tremor performance and ADL tasks as well additional functional tasks. Success criteria include 1) development and validation of signal processing algorithms that correlate (r ≥ 0.76, root-mean-square error ≤0.5) kinematic data with clinician's TETRAS-based tremor performance and ADL scores, and 2) development and validation of machine learning models that accurately (sensitivity/ specificity/AUC > 0.8) identify physical activities such as walking, sitting, standing, getting out of a chair, going up and down stairs.

概括目标是设计 ETAware 并进行临床评估，这是一种自适应可穿戴系统，用于监测影响震颤对日常生活活动 (ADL) 的影响，用于评估和优化治疗干预措施特发性震颤 (ET) 患者，因为目前没有技术可以评估功能影响 ADL 上的震颤将重点关注 ET，这是最常见的运动障碍，影响着 1000 万人。在美国；然而，在商业上，该系统将适用于阻碍参与的其他条件目前，普萘洛尔和扑米酮是用于日常活动并影响生活质量的两种主要药物。治疗特发性震颤，同时进行深部脑刺激 (DBS) 和 MRI 引导等手术干预聚焦超声 (MgFUS) 对于医学难治性 ET 是必要的，但患者对所有治疗的反应都不同。治疗的形式可能有很大差异，因此需要顺序使用不同的药物。干预措施的有效性，量化震颤严重程度及其对 ET 中 ADL 的影响至关重要。目前，为了显示临床改善，使用主观问卷和评分量表。这些问卷和评级量表受到临床判断和偏见的影响，仅提供一定程度的信息离散时间点，无法用于日常连续监控，ETAware 将持续监控。震颤的严重程度以及震颤对 ADL 的功能影响，这将有助于依从者调整治疗，帮助患者控制他们的疾病管理，并通过提供客观的生活质量衡量，并最大限度地减少与诊所就诊和管理相关的成本问卷和评级量表。我们之前已经将可穿戴设备和移动应用程序商业化，目前用于药物临床试验用于监测上肢震颤严重程度然而，现有系统无法量化下肢震颤或提供有关震颤对 ADL 影响的任何信息 ETAware 的主要创新是 1) 信号。处理算法来分析运动传感器数据并提供功能的连续测量震颤对 ADL 的影响，2) 一个供忠诚者优化治疗、供研究人员评估和开发的系统新疗法，以及患者继续参与疾病管理。为了证明第一阶段的可行性，将从 20 名特发性震颤患者收集运动数据同时他们正在执行基于 TETRAS 的震颤性能和 ADL 任务以及其他功能任务。成功标准包括 1) 开发和验证相关的信号算法处理（r ≥ 0.76，均方根误差≤0.5）运动学数据与临床医生基于TETRAS的震颤表现和ADL 分数，以及 2) 开发和验证准确（灵敏度/ 特异性/AUC > 0.8）识别身体活动，例如行走、坐着、站立、从椅子上站起来、走动上下楼梯。