PDRemote: Automated Telehealth Diagnostics for Remote Parkinson's Monitoring

描述(由申请人提供)：目标是建立和临床评估PDRemote，这是一个用于远程帕金森病(PD)监测的自动化远程健康诊断系统。目前在美国，大约有150万患者患有帕金森病，每年报告的新病例为5万例。然而，该人群中的很大一部分人进入运动障碍专家中心的机会有限，而且远程持续监测运动症状以捕获复杂波动模式和优化治疗方案的机会也有限。帕金森病的特征是手指、手、头和脖子震颤，运动迟缓和肌肉僵硬。治疗方法包括药物干预，如左旋多巴和外科手术，如脑深部刺激(DBS)。准确地量化帕金森病患者的运动功能和残疾是很重要的 评估干预效果。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(UPDRS)，用于显示帕金森病的临床改善。虽然UPDRS已经显示出临床实用价值，但它需要临床医生在场才能进行评分，并且只能在诊所就诊时获得症状的快照。此外，对于地理上不同的帕金森病人群或无法旅行的人来说，寻求运动障碍专家的有效运动症状监测和管理至关重要。运动障碍中心的位置可能会限制许多PD患者接触训练有素的临床医生和有效的症状管理。可以改善这些患者获得机会的远程医疗技术可能会对远程患者或无法旅行的患者的公平性、可获得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，以准确量化干预效果并限制治疗调整所需的办公室就诊次数，从而改善结果并降低不同患者群体的成本。帕金森病患者将被送回家，带着患者套件，包括一台符合人体工程学设计的触摸屏平板电脑、直观的日记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被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与患者的视频会议进行审查，以做出适当的药物改变。在第一阶段，患者成功地在家里使用患者套件进行运动评估，临床医生成功地使用基于网络的应用程序开出测试处方和查看报告，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 使用该系统可以减少波动，减少办公室就诊，并改善患者结果。

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.