Wireless Movement Disorder Monitor

描述（由申请人提供）：目的是设计、构建和临床评估ParkinSense，一种用于帕金森病（PD）的无线运动障碍监测仪。影响生活质量的三种主要PD症状包括震颤、运动迟缓和运动障碍。这些症状通常导致功能障碍和社交尴尬。目前评估症状的标准是统一帕金森病评定量表（Unified Parkinson's Disease Rating Scale，简称EADS），这是一种定性评级系统。客观量化PD症状将有助于评估治疗方案。在家监测症状将使临床医生能够捕捉治疗反应的复杂波动模式，而不是仅在办公室访问期间进行检查或依赖于患者日志。患者佩戴硬件由小型、轻质组件组成。手指单元容纳正交加速度计和陀螺仪测量三维运动。腕部单元提供数据采集、存储器、电源、肌电图（EMG）放大器和用于无线数据传输的蓝牙无线电。临床接口软件收集、处理和呈现运动和EMG。在第II阶段，从数据中处理定量变量，并应用于算法，以评估震颤、运动迟缓和僵硬的严重程度。Phase II ParkinSense系统在客观量化临床症状方面表现出色。这一拟议的第二阶段继续赠款的主要目标是完成家庭使用的最后系统修改。此外，将设计一项大型多中心临床试验，以进一步验证和改进算法，并评估在患者家中的使用。这些数据对于证明安全性和有效性以获得食品和药物管理局的上市许可至关重要。首先，患者单元的尺寸和重量将最小化。接下来，该软件将进行重大升级，以供家庭使用，包括报告功能和改进的用户反馈。将设计一个基础设施，从患者家中远程检索报告。最后，ParkinSense将在一项大型多中心临床研究和PD受试者家中进行测试。来自临床试验的数据将用于进一步验证和改进在第二阶段工作中开发的自动检测和症状严重程度评级算法。我们假设ParkinSense将捕获与定性临床医生评分和震颤、运动迟缓和运动障碍的患者事件标记相关的症状变量。此外，为了说明成功，ParkinSense应在家中成功使用，PD受试者应具有高水平的器械接受度。

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinSense", a wireless movement disorder monitor for Parkinson's disease (PD). Three major PD symptoms that affect quality of life include tremor, bradykinesia, and dyskinesias. These symptoms are often responsible for functional disability and social embarrassment. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. Objectively quantifying PD symptoms would aid in evaluating treatment protocols. Monitoring symptoms at home would allow a clinician to capture complex fluctuation patterns in treatment response instead of only examining during an office visit or relying on patient journals. The patient worn hardware consists of small, lightweight components. A finger unit housing orthogonal accelerometers and gyroscopes measures three-dimensional motion. A wrist unit provides data acquisition, memory, power, electromyography (EMG) amplifiers, and a Bluetooth" radio for wireless data transmission. Clinical interface software collects, processes, and presents motion and EMG. During Phase II quantitative variables were processed from the data and applied to algorithms to assess severity of tremor, bradykinesia, and rigidity. The Phase II ParkinSense system showed excellent results to objectively quantify symptoms in the clinic. The main goal of this proposed Phase II continuation grant is to complete final system modifications for home use. Additionally, a large multi-center clinical trial will be designed to further validate and improve algorithms and evaluate use in patient homes. This data is critical to proving safety and effectiveness to obtain Food and Drug Administration clearance to market. First, the patient unit size and weight will be minimized. Next, the software will be significantly upgraded for home use including reporting features and improved user feedback. An infrastructure will be designed to retrieve reports remotely from patient homes. Finally, ParkinSense will be tested in a large, multi-center clinical study and in the homes of PD subjects. Data from the clinical trials will be used to further validate and improve automated detection and symptom severity rating algorithms developed during the Phase II effort. We hypothesize ParkinSense will capture symptom variables that correlate to qualitative clinician scoring and patient event marking of tremor, bradykinesia, and dyskinesias. In addition, to illustrate success ParkinSense should be successfully used at home and PD subjects should have a high level of device acceptance.