PDRemote: Automated Telehealth Diagnostics for Remote Parkinson's Monitoring

描述（由申请人提供）：目的是构建和临床评估PDRemote，这是一种用于远程帕金森病（PD）监测的自动远程医疗诊断系统。目前在美国，大约有150万患者患有PD，每年报告5万例新病例。然而，对于这一人群的很大一部分来说，进入运动障碍专家中心的机会有限，并且远程连续监测运动症状以捕获复杂的波动模式并优化治疗方案的机会有限。PD的特征在于手指、手、头和颈部的震颤、运动迟缓（运动减慢）和肌肉组织僵硬。治疗包括药物干预，如左旋多巴和外科手术，如脑深部电刺激（DBS）。准确量化PD患者的运动功能和残疾是非常重要的 评估干预的有效性。目前，主观临床评定量表，最常见的是统一帕金森病评定量表（Unified Parkinson's Disease Rating Scale，简称CAFRS），用于显示PD的临床改善。虽然CIMRS已显示出临床实用性，但它需要临床医生在场进行评分，并且仅在临床办公室访视期间获得症状快照。此外，获得运动障碍专家的有效运动症状监测和管理是至关重要的地理上不同的子集的PD人群或那些不能旅行。运动障碍中心的位置可能会限制许多PD患者获得训练有素的临床医生和有效的症状管理。远程医疗技术可以改善这些患者的就医机会，可以对偏远地区或无法旅行的患者的公平性、可及性和病情管理产生重大影响。PDRemote将提供远程、自动化的运动症状严重程度评分，以准确量化干预有效性并限制治疗调整所需的就诊次数，从而改善不同患者群体的结果并降低成本。PD患者将被送回家，患者套件包括符合人体工程学设计的触摸屏平板电脑、日记的直观软件界面和无线运动传感器单元。从家庭会议收集的数据将无线传输到在线数据库，该数据库生成运动症状严重程度报告，供临床医生通过基于网络的界面和视频会议与患者进行审查，以做出适当的药物改变。在第一阶段，患者在家中成功使用患者工具包进行运动评估，临床医生成功使用基于网络的应用程序进行处方测试和查看报告，从而证明了可行性。第二阶段将进一步改善人体工程学、数据传输、报告能力，并产生可临床部署的技术。该系统将用于多中心临床试验，以确定是否 使用该系统可以减少波动，减少办公室访问，并改善患者的结果。 公共卫生相关性：帕金森氏病的主要特征是震颤、运动迟缓（运动减慢）和僵硬的运动症状，这些症状可能非常虚弱，导致活动性、独立性和生活质量下降。临床医生缺乏定量工具来进行更连续的监测，以捕捉运动症状如何在白天波动，以响应治疗方案，以帮助最大限度地减少帕金森氏症的运动症状。PDRemote将是一个可重复的自动化系统，临床医生将用于在患者家中更连续地远程监测PD运动症状，这将改善结果并降低成本，特别是对于不靠近运动障碍专家的不同患者人群。

DESCRIPTION (provided by applicant): The objective is to build and clinically assess PDRemote, a system for automated telehealth diagnostics for remote Parkinson's disease (PD) monitoring. Currently in the United States, there are approximately 1.5 million patients living wit PD and 50,000 new cases reported each year. However, there is limited access to movement disorder specialist centers for a significant portion of this population as well as limited opportunity for remote continuous monitoring of motor symptoms to capture complex fluctuation patterns and optimize treatment protocols. PD is characterized by tremors of the fingers, hands, head, and neck, bradykinesia (slowed movements), and rigidity of musculature. Treatments include pharmaceutical interventions such as levodopa and surgical procedures such as deep brain stimulation (DBS). It is important to accurately quantify motor function and disability in PD to assess intervention efficacy. Currently, subjective clinical rating scales, most commonly the Unified Parkinson's Disease Rating Scale (UPDRS), are used to show clinical improvement in PD. While the UPDRS has shown clinical utility, it requires presence of a clinician for scoring and only obtains a snapshot of symptoms during a clinical office visit. Furthermore, access to movement disorder specialists for effective motor symptom monitoring and management is critical for a geographically disparate subset of the PD population or those unable to travel. The location of movement disorder centers can limit access to well-trained clinicians and effective symptom management for many PD patients. Telehealth technologies that can improve access for these patients can have a significant impact on the equity, accessibility, and management of the condition for remote patients or those unable to travel. PDRemote will provide remote, automated, motor symptom severity scoring to accurately quantify intervention effectiveness and limit the required number of office visits for treatment adjustments, thereby improving outcomes and decreasing costs for disparate patient populations. PD patients will be sent home with patient kit including an ergonomically designed touch-screen tablet PC, intuitive software interface for diaries, and a wireless motion sensor unit. Data collected from home sessions will be wirelessly transmitted to an online database that generates a motor symptom severity report for clinicians to review via a web-based interface and video conference with a patient to make appropriate medication changes. Feasibility was demonstrated in Phase I by patients successfully using the patient kit in the home to perform motor assessments and clinicians successfully using the web-based application to prescribe tests and view reports. Phase II will further improve ergonomics, data transfer, reporting capabilities, and result in a clinically deployable technology. The system will be employed in a multi-center clinical trial to determine if using the system can reduce fluctuations, decrease office visits, and improve patient outcomes. PUBLIC HEALTH RELEVANCE: Parkinson's disease is primarily characterized by motor symptoms of tremor, bradykinesia (slowed movements), and rigidity which can be very debilitating, leading to decreased mobility, independence, and quality of life. Clinicians lack quantitative tools for more continuous monitoring that capture how motor symptoms fluctuate during the day in response to treatment protocols to help minimize Parkinson's motor symptoms. PDRemote will be a repeatable, automated system clinicians will use to remotely monitor PD motor symptoms on a more continuous basis in a patient's home that should improve outcomes and decrease costs especially for disparate patient populations in areas not in close proximity to movement disorder specialists.