ParkinStep: Automated PD Gait and Balance Assessment for Optimizing DBS

描述（由申请人提供）：目的是设计、构建和临床评估“ParkinStep”，一种紧凑、便携、无线运动障碍监测技术，用于量化帕金森病（PD）患者的步态和平衡表现。用于评估步态和平衡以响应脑深部电刺激（DBS）设置的标准化可重复自动测试平台应优化患者结局，并为针对步态和平衡的新DBS方案提供新的研究工具。目前，PD病理生理学和治疗（包括药物干预和DBS）的研究有了巨大的增长和积极的研究。疗效通过患者症状的缓解和生活质量的改善来判断。初次DBS手术后，几次随访检查优化了刺激参数，以最大限度地减少运动症状和副作用，延长电池寿命，并减少所需的药物治疗。目前的症状评估标准是统一帕金森病评定量表（Unified Parkinson's Disease Rating Scale，简称CAFRS），这是一个定性的分级系统。在DBS程控会话期间，神经科医生通常使用一部分OSAS运动检查评估上肢功能。虽然步态和平衡是生活质量测量的关键组成部分，并且不规则的下肢功能可能会导致残疾，但这些通常比上肢同行受到较少关注。CleveMed此前开发了一种名为ParkinSense的技术平台，用于量化上肢PD运动症状。已经对PD受试者进行了临床试验，以定量评估震颤和运动迟缓的严重程度。输出与临床医生的定性评分高度相关。此外，与使用离散的视觉观察相比，客观的定量ParkinSense输出评分在连续尺度上提供了更高的分辨率。迄今为止，步态和平衡仅需进行微小的硬件升级，临床效果良好，这一先前存在的基础提高了项目成功的可能性。我们假设ParkinStep将成功捕获与步态和平衡相关的定量症状变量，将这些变量处理为算法，其输出与步态和平衡的定性临床医生评分相关，并证明患者和临床医生的临床可接受性较高。这一发展将继续CleveMed的道路，提供一个标准化的平台，定量评估的所有组成部分的ECONORS运动部分。公共卫生相关性：帕金森氏病的主要特征是震颤、运动迟缓和僵硬的"经典"运动症状;然而，其他下肢症状如平衡和步态障碍，特别是在晚期患者中，可能非常虚弱，导致活动性和独立性降低，生活质量下降和跌倒/髋部骨折风险增加。临床医生缺乏定量工具来优化深部脑刺激编程以缓解帕金森氏症的运动症状。ParkinStep "将是一种可重复的自动化工具，可以量化下肢运动功能，并在门诊随访期间辅助刺激编程，以优化患者结局。

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinStep", a compact, portable, wireless movement disorder monitor technology to quantify gait and balance performance in Parkinson's disease (PD). A standardized platform for repeatable, automated testing to assess gait and balance in response to deep brain stimulation (DBS) settings should optimize patient outcomes and provide a novel research tool for new DBS protocols targeted to gait and balance. There has currently been tremendous growth and active research into PD pathophysiology and treatment including pharmaceutical interventions and DBS. Efficacy is judged by alleviation of patient symptoms and improved quality of life. After initial DBS surgery, several follow-up examinations optimize stimulation parameters to minimize motor symptoms and side effects, increase battery life, and decrease required drug therapy. The current standard in symptom evaluation is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. During DBS programming sessions, a neurologist typically assesses upper extremity function using a subset of the UPDRS motor exam. While gait and balance are critical components to quality of life measures and irregular lower extremity function can be disabling, these often receive less attention than upper extremity counterparts. CleveMed has previously developed a technology platform called ParkinSense" to quantify upper extremity PD motor symptoms. Clinical trials have been conducted with PD subjects to quantitatively assess severity of tremor and bradykinesia. Outputs were highly correlated with clinicians' qualitative UPDRS scores. Additionally, the objective, quantitative ParkinSense output scores provided increased resolution on a continuous scale compared to visual observations using the discrete UPDRS. With only minor hardware upgrades required for gait and balance and excellent clinical results to date, this previously existing base enhances likelihood of project success. We hypothesize ParkinStep will successfully capture quantitative symptom variables related to gait and balance, process those variables into a algorithm whose output correlates to qualitative clinician scoring of gait and balance, and demonstrate high clinical acceptability by both patients and clinicians. This development will continue CleveMed's path to providing a standardized platform for quantitatively assessing all components of the UPDRS motor section. PUBLIC HEALTH RELEVANCE: Parkinson's disease is primarily characterized by the "classic" motor symptoms of tremor, bradykinesia, and rigidity; however, other lower extremity symptoms such as balance and gait disturbances, especially in advanced patients, can be very debilitating, leading to decreased mobility and independence, decreased quality of life and an increased falling/hip fracture risk. Clinicians lack quantitative tools to optimize deep brain stimulation programming for alleviating Parkinson's motor symptoms. ParkinStep" will be a repeatable, automated tool that can quantify lower extremity motor function and assist stimulation programming during outpatient follow up to optimize patient outcomes.