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，一个用于远程帕金森病（PD）监测的自动远程医疗诊断系统。目前在美国，大约有150万PD患者，每年有5万例新病例报告。然而，对于这一人群的很大一部分来说，进入运动障碍专科中心的机会有限，远程连续监测运动症状以捕捉复杂的波动模式和优化治疗方案的机会也有限。PD的特点是手指、手、头部和颈部震颤，运动迟缓（运动缓慢）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，如深部脑刺激（DBS）。准确量化PD患者的运动功能和残疾是非常重要的

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.