BradyXplore: Bradykinesia Feature Extraction System

描述(由申请人提供)：目标是设计、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“，以便与CleveMed现有的帕金森感觉”技术平台轻松集成。特发性帕金森氏病(PD)和其他帕金森氏症影响着数百万人。导致功能障碍和生活质量下降的三个主要症状包括震颤、运动迟缓和僵硬。目前评估症状的标准是统一的帕金森氏病评定量表(UPDRS)，这是一个主观的、定性的排名系统。虽然震颤通常是最明显的症状，但运动迟缓对患者的损害可能最大。客观地量化运动迟缓将有助于评估治疗方案的疗效。更具体地说，针对运动迟缓的UPDRS评分说明将多个特征整合到一个评分中，这可能会导致评分者之间的评分差异增加，并限制了探索特定运动迟缓特征是否受到特定治疗方案影响的机会。CleveMed此前开发了一种紧凑型无线系统，用于量化运动障碍症状，称为帕金森病。这项先前存在的技术将作为这一拟议计划的硬件平台。在一项临床研究中，该系统成功地展示了PD运动症状的客观量化。量化变量被处理并应用于算法来评估症状严重程度。算法输出与临床医生对静息、姿势和运动性震颤的定性UPDRS评分高度相关。虽然对于运动迟缓也取得了中等的结果，但这一应用程序解决了运动迟缓特征提取的优化问题，包括速度、幅度和节奏。UPDRS使用三项任务来评估运动迟缓的严重程度，评分为0-4分：手指轻敲；手张开-闭合；旋前-旋后。患者被指示以尽可能快的速度和尽可能大的距离重复完成每项任务。指导临床医生记分员考虑运动中的速度、幅度、疲劳、犹豫、停顿，以及这些变量如何随时间变化。即使对于最有经验的运动障碍专家来说，解释所有这些变量也是具有挑战性的。很难测量特定临床医生对不同运动迟缓表现的权重。此外，目前还不清楚不同表现的潜在神经机制是否相同。客观地量化特定的运动迟缓特征将有助于开发针对特定运动迟缓表现的新的DBS疗法。此外，用于更连续监测的便携式平台将允许临床医生捕获治疗反应中的复杂波动模式。与公共卫生相关：帕金森氏症在美国影响着100多万人，导致运动症状，其中最令人虚弱的是运动迟缓(运动减慢)。目前使用主观评分表评估运动迟缓，该量表考虑到运动中的速度、幅度、疲倦、犹豫、停顿以及这些变量如何随着时间的变化而给出一个单一的分数。建议的BradyXplore运动迟缓特征提取系统将分别量化运动迟缓的特定特征(速度、幅度和节奏)，这将有助于开发针对患者特定运动迟缓表现的新疗法。

DESCRIPTION (provided by applicant): The objective is to design, implement, and clinically assess a portable, user worn, bradykinesia feature extraction system, BradyXplore", for easy integration with CleveMed's existing ParkinSense" technology platform. Idiopathic Parkinson's disease (PD) and other parkinsonian disorders affect millions of people. Three major symptoms responsible for functional disability and reduced quality of life include tremor, bradykinesia, and rigidity. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. While tremor is often the most visible symptom, bradykinesia can be the most impairing to the patient. Objectively quantifying bradykinesia would aid in evaluating treatment protocol efficacy. More specifically, UPDRS scoring instructions for bradykinesia integrates multiple features into a single score that may cause increased inter-rater variability in scores as well as limit the opportunity to explore if particular bradykinesia features are influenced by specific treatment protocols. CleveMed has previously developed a compact wireless system to quantify movement disorder symptoms called ParkinSense". This previously existing technology will serve as the hardware platform for this proposed program. In a clinical study, this system successfully demonstrated objective quantification of PD motor symptoms. Quantitative variables were processed and applied to algorithms to assess symptom severity. Algorithm outputs were highly correlated with clinicians' qualitative UPDRS scores for rest, postural, and kinetic tremor. While moderate results were also achieved for bradykinesia, this application addresses optimization of bradykinesia feature extraction including speed, amplitude, and rhythm. The UPDRS uses three tasks to evaluate bradykinesia severity on a 0-4 scale: finger taps; hand opening- closing; and pronation-supination. Patients are instructed to repetitively complete each task as fast and with as wide an excursion as they can. Clinician scorers are instructed to account for speed, amplitude, fatiguing, hesitations, arrests in movement, and how these variables change over time. Accounting for all of these variables is challenging, even for the most experienced movement disorder specialist. It is difficult to gauge weights specific clinicians place on different bradykinesia manifestations. Also, it is unclear if underlying neural mechanisms for different manifestations are the same. Objectively quantifying specific bradykinesia features should aid in the development of novel DBS therapies for targeting specific bradykinesia manifestations. Furthermore, a portable platform for more continuous monitoring will allow a clinician to capture complex fluctuation patterns in treatment response. PUBLIC HEALTH RELEVANCE: Parkinson's disease affects more than 1,000,000 people in the United States causing motor symptoms of which one of the most debilitating is bradykinesia (slowed movements). Bradykinesia is currently evaluated using a subjective rating scale that gives a single score taking into account speed, amplitude, fatiguing, hesitations, arrests in movement, and how these variables change over time. The proposed BradyXplore bradykinesia feature extraction system will separately quantify specific features of bradykinesia (speed, amplitude, and rhythm), which should aid in the development of novel therapies to target a patient's specific bradykinesia manifestations.