Wireless Movement Disorder Monitor

描述(由申请人提供)：目标是设计、建造和临床评估帕金森氏病(PD)的无线运动障碍监测器“帕金森感觉”。影响生活质量的三种主要帕金森病症状包括震颤、运动迟缓和运动障碍。这些症状通常会导致功能障碍和社交尴尬。目前评估症状的标准是统一的帕金森氏病评定量表(UPDRS)，这是一个定性的排名系统。客观地量化帕金森病症状将有助于评估治疗方案。在家中监测症状将使临床医生能够捕获治疗反应中复杂的波动模式，而不是只在办公室就诊时检查或依赖患者日记。患者佩戴的硬件由体积小、重量轻的部件组成。一个装有正交加速度计和陀螺仪的手指单元可以测量三维运动。手腕单元提供数据采集、存储、电源、肌电(EMG)放大器和用于无线数据传输的蓝牙“无线电。临床界面软件收集、处理和呈现运动和肌电。在第二阶段，从数据中处理定量变量，并将其应用于算法，以评估震颤、运动迟缓和僵硬的严重程度。第二阶段帕金森系统在临床上客观量化症状方面显示出极好的结果。这项拟议的第二阶段续期赠款的主要目标是完成家庭使用的最终系统改造。此外，还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，并评估患者之家的使用情况。这些数据对于证明获得食品和药物管理局批准上市的安全性和有效性至关重要。首先，患者单元的大小和重量将被最小化。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，以便从患者家中远程检索报告。最后，ParkinSense将在一项大型、多中心的临床研究中和帕金森病患者的家中进行测试。临床试验的数据将被用来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。我们假设帕金森病将捕获与临床医生的定性评分和震颤、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，帕金森综合症应该在家里成功使用，帕金森综合症患者应该有很高的设备接受度。

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.