BradyXplore: Bradykinesia Feature Extraction System

描述（由申请人提供）：目的是设计、实施和临床评估便携式、用户佩戴的运动迟缓特征提取系统“BradyXplore”，用于与Great Lake Neurotechnologies（GLN）Kinesia和Kinesia HomeView技术平台集成，用于客观监测帕金森病（PD）。对PD治疗进行了大量研究，包括药物干预和脑深部电刺激（DBS）。虽然震颤通常是最明显的症状，但运动迟缓可能是最有害的。目前评价运动迟缓的标准是统一帕金森病评定量表，这是一种主观的定性排名系统。运动迟缓的评分说明将多个运动特征整合到单个评分中，这增加了变异性并限制了对特定运动迟缓特征是否受特定治疗影响的探索。如果能更好地量化不同的运动迟缓特征，就可能开发出针对特定运动迟缓表现的新疗法。提出的创新包括1）紧凑的、用户佩戴的运动传感器，其可以与家用计算机或平板电脑上的基于网络的软件一起使用，2）使用运动学数据来独立地评定速度、幅度和节奏的算法，以及3）用于系统递送、患者交互和症状报告的基于网络的应用，所有这些都将促进临床接受和自我维持的商业模式。包含加速计和陀螺仪的无线运动传感器单元将戴在手指和拇指上，并收集同步运动数据。BradyXplore将为标准重复运动任务独立评定速度、幅度和节奏。传感器单元电池将通过感应式USB充电板充电，以消除患者对小型连接器的烦躁不安。当传感器单元放置在垫上时，运动学数据将通过无线链路传输到患者的计算机或平板电脑，然后上传到我们的符合HIPAA的服务器。在第一阶段，我们成功升级现有的运动传感器单元，以减小尺寸并提高灵敏度。算法被开发用于独立地评定速度、幅度和节奏。算法输出的评分与临床评级高度相关，并显示出速度、振幅和节律对药物的不同反应。第二阶段将改进人体工程学、灵敏度、数据传输和报告。硬件将升级，包括两个同步传感器单元，通过感应板充电，并通过低功耗无线电传输数据。软件将被修改为完全基于网络，因此患者无需安装任何软件。将在临床研究中进一步研究BradyXplore算法，以证明其与临床评级相比的重测可靠性，并确定DBS上的速度、振幅和节律波动是否存在差异。我们假设，BradyXplore将1）为运动迟缓评估提供标准化平台，客观量化速度、振幅和节律，2）获得临床医生和患者的高度临床接受度，3）帮助开发、评价和优化DBS和药物干预等治疗。

DESCRIPTION (provided by applicant): The objective is to design, implement, and clinically assess a portable, user-worn, bradykinesia feature extraction system, BradyXplore", for integration with Great Lake Neurotechnologies' (GLN) Kinesia and Kinesia HomeView technology platforms for objective Parkinson's disease (PD) monitoring. There has been tremendous research into PD treatments including pharmaceutical interventions and deep brain stimulation (DBS). While tremor is often the most visible symptom, bradykinesia can be the most impairing. The current standard in evaluating bradykinesia is the Unified Parkinson's Disease Rating Scale, a subjective, qualitative ranking system. Scoring instructions for bradykinesia integrate multiple movement features into a single score that increases variability and limits exploration into if particular bradykinesia features are influenced by specific treatments. If different bradykinesia features were better quantified, novel therapies may be developed to target specific bradykinesia manifestations. The proposed innovations include 1) compact, user-worn motion sensors that can be used with web-based software on a home computer or tablet, 2) algorithms that use kinematic data to rate speed, amplitude, and rhythm independently, and 3) web-based applications for system delivery, patient interaction, and symptom reporting, all of which will promote clinical acceptance and a self- sustaining business model. Wireless motion sensor units containing accelerometers and gyroscopes will be worn on the finger and thumb and collect synchronized motion data. BradyXplore will independently rate speed, amplitude, and rhythm for the standard repetitive motion tasks. Sensor unit batteries will be recharged by an inductive, USB charge pad to eliminate the need for patients to fidget with small connectors. When sensor units are placed on the pad, kinematic data will be transferred to the patient's computer or tablet via a wireless link and then uploaded to our HIPAA-compliant server. In Phase I, our existing motion sensor unit was successfully upgraded to reduce size and improve sensitivity. Algorithms were developed for independently rating speed, amplitude, and rhythm. The algorithms output scores highly correlated to clinical ratings and demonstrated a differential response of speed, amplitude, and rhythm to medication. Phase II will improve ergonomics, sensitivity, data transfer, and reporting. Hardware will be upgraded to include two synchronized sensor units that recharge via an inductive pad and transfer data via a low-power radio. Software will be modified to be completely web-based so patients need not install any software. BradyXplore algorithms will be further investigated in a clinical study to demonstrate its test-retest reliability compared to clinical ratings and determine if speed, amplitude, and rhythm fluctuate differentially ON DBS. We hypothesize that BradyXplore will 1) provide a standardized platform for bradykinesia assessment that objectively quantifies speed, amplitude, and rhythm, 2) receive high clinical acceptance from both clinicians and patients, and 3) aid in development, evaluation, and optimization of therapies such as DBS and pharmaceutical interventions.