ParkinStep: Automated PD Gait and Balance Assessment for Optimizing DBS

ParkinStep：用于优化 DBS 的自动 PD 步态和平衡评估

• 批准号: 7746783
• 负责人: JOSEPH P GIUFFRIDA
• 金额: $ 24.83万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7746783
• 关键词: Adverse effects; Affect; Algorithms; Amplifiers; Attention; Bradykinesia; Clinical; Clinical Research; Clinical Trials; Complex; Computer software; Custom; Data; Deep Brain Stimulation; Development; Devices; Diagnostic; Disease; Dystonia; Electromyography; Equilibrium; Evaluation; Feedback; Figs - dietary; Fingers; Functional disorder; Gait; Gait abnormality; Growth; Hip Fractures; Home environment; Housing; Human; Huntington Disease; Intervention; Life; Lower Extremity; Measures; Memory; Minor; Modification; Monitor; Motion; Motor; Movement; Movement Disorders; Muscle Rigidity; Neurologist; Operative Surgical Procedures; Outcome; Outcome Assessment; Outpatients; Output; Parkinson Disease; Patients; Pattern; Performance; Pharmacologic Substance; Pharmacotherapy; Phase; Process; Protocols documentation; Quality of life; Radio; Reporting; Research; Research Personnel; Resolution; Risk; Severities; Symptoms; System; Technology; Testing; Time; Treatment Efficacy; Tremor; Upper Extremity; Visual; Wireless Technology; base; computerized data processing; data acquisition; data exchange; design; falls; follow-up; improved; insight; movie; novel; patient safety; programs; prototype; public health relevance; response; sensor; success; tool

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.

描述（由申请人提供）：目标是设计、构建和临床评估ParkinStep，这是一种紧凑、便携式、无线运动障碍监测技术，用于量化帕金森病（PD）的步态和平衡表现。一个标准化的可重复的自动化测试平台，用于评估脑深部刺激（DBS）设置下的步态和平衡，应优化患者的结果，并为针对步态和平衡的新DBS方案提供一种新的研究工具。目前，PD的病理生理和治疗，包括药物干预和DBS，已经有了巨大的增长和活跃的研究。疗效是通过患者症状的缓解和生活质量的改善来判断的。在最初的DBS手术后，几次随访检查优化刺激参数，以尽量减少运动症状和副作用，延长电池寿命，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（UPDRS），这是一种定性排名系统。在DBS编程过程中，神经科医生通常使用UPDRS运动检查的一个子集来评估上肢功能。虽然步态和平衡是衡量生活质量的关键组成部分，但下肢功能不正常可能会导致残疾，但这些通常比上肢得到的关注要少。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。临床试验已在PD受试者中进行，以定量评估震颤和运动迟缓的严重程度。结果与临床医生的定性UPDRS评分高度相关。此外，与使用离散UPDRS的视觉观察相比，客观、定量的ParkinSense输出分数在连续尺度上提供了更高的分辨率。迄今为止，仅需要对步态和平衡进行轻微的硬件升级，并且临床效果良好，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，将这些变量处理成一个算法，其输出与临床医生对步态和平衡的定性评分相关，并证明患者和临床医生的临床可接受性很高。这一发展将继续CleveMed的道路，为定量评估UPDRS电机部分的所有组件提供标准化平台。公共卫生相关性：帕金森病的主要特征是震颤、运动迟缓和僵硬等“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，可能会使人非常虚弱，导致活动能力和独立性下降，生活质量下降，摔倒/髋部骨折的风险增加。临床医生缺乏定量工具来优化脑深部刺激程序，以减轻帕金森病的运动症状。ParkinStep”将是一个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计划，以优化患者的治疗效果。