ParkinTune: Automated PD Motor Symptom Assessment for DBS Programming

描述(由申请人提供)：目标是设计、构建和临床评估ParkinTune，这是一种先进的无线运动障碍监测技术，用于增强帕金森氏病(PD)脑深部刺激(DBS)程序中涉及的刺激编程(调谐)。影响生活质量的主要帕金森病症状包括震颤、运动迟缓和僵硬。虽然推动DBS临床成功故事的确切机制尚不清楚，但已证明当药物不再有效时，该程序可有效缓解PD运动症状。然而，临床医生缺乏结合生理、电和行为数据来优化电极放置和刺激器编程的工具。优化电极放置和刺激器参数可改善患者接受的运动症状减轻量，并将并发症降至最低。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。一系列练习，通常是UPDRS上肢运动部分的子集，通常在DBS电极放置手术和随后的编程会议期间完成，以评估性能，同时临床医生定性评估症状。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。虽然以前的工作已经显示出在临床检查期间客观量化症状的出色结果，但这个拟议的项目将集成几个新功能，用于实时辅助DBS手术电极放置和刺激编程。由这一建议的Fast-Track应用程序产生的临床可部署的ParkinTune系统将提供一个紧凑的无线系统，用于手术室和门诊随访编程会议，最大限度地提高患者的安全性和舒适性。在电极放置和后续编程期间传输的客观生物动力学数据将被输入到算法中，该算法实时输出客观PD症状严重程度的连续量表，以指导临床医生的决策。ParkinTune系统提高的分辨率和可重复的结果应该会减少DBS程序的时间和成本，并优化患者的结果。与公共卫生相关。虽然推动深部脑刺激临床成功故事的确切机制尚不清楚，但当药物不再有效时，该程序有效地缓解了帕金森病的运动症状。然而，临床医生缺乏结合生理、电和行为数据来优化电极放置和刺激器编程的工具。ParkinTune“是一种可重复的自动化工具，可以量化运动症状，将在手术电极放置和门诊随访期间帮助进行刺激编程，以优化患者结果并减少相关的时间和成本。

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinTune", an advanced wireless movement disorder monitor technology to augment stimulation programming (tuning) involved in deep brain stimulation (DBS) procedures for Parkinson's Disease (PD). Major PD symptoms that affect quality of life include tremor, bradykinesia, and rigidity. While the exact mechanism that fuels DBS clinical success stories remains unclear, the procedure has been shown to effectively relieve PD motor symptoms when medication is no longer effective. However, clinicians lack tools that combine physiological, electrical, and behavioral data to optimize electrode placement and stimulator programming. Optimizing electrode placement and stimulator parameters improves the amount of motor symptom reduction patients receive and minimizes complications. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a qualitative ranking system. A battery of exercises, typically a subset of the upper extremity motor section of the UPDRS, is normally completed during DBS electrode placement surgery and subsequent programming sessions to evaluate performance while a clinician qualitatively assesses symptoms. 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. While previous work has shown excellent results to objectively quantify symptoms during a clinical exam, this proposed project will integrate several new features for real-time assistance with DBS surgery electrode placement and stimulation programming. The clinically deployable ParkinTune system resulting from this proposed Fast-Track application will provide a compact wireless system for use in the operating room and outpatient follow up programming sessions that maximizes patient safety and comfort. The objective biokinetic data transmitted during electrode placement and subsequent programming will be input to algorithms that output a continuous scale of objective PD symptom severity in real-time to guide clinician decision making. The improved resolution and repeatable results of the ParkinTune system should reduce time and costs of DBS procedures as well as optimize patient outcomes. PUBLIC HEALTH RELEVANCE. While the exact mechanism that fuels deep brain stimulation clinical success stories remains unclear, the procedure effectively relieves Parkinson's disease motor symptoms when medication is no longer effective. However, clinicians lack tools that combine physiological, electrical, and behavioral data to optimize electrode placement and stimulator programming. ParkinTune", a repeatable, automated tool that can quantify motor symptoms will assist stimulation programming during surgical electrode placement and outpatient follow up to optimize patient outcomes and reduce associated time and costs.