ParkinTune: Automated PD Motor Symptom Assessment for DBS Programming

ParkinTune：用于 DBS 编程的自动 PD 运动症状评估

• 批准号: 7922938
• 负责人: JOSEPH P GIUFFRIDA
• 金额: $ 49.95万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7922938
• 关键词: Adverse effects; Affect; Algorithms; Ambulatory Surgical Procedures; Amplifiers; Behavioral; Biomedical Engineering; Bradykinesia; Cell Transplants; Clinic; Clinical; Clinical Research; Clinical Trials; Complication; Computer software; Data; Decision Making; Deep Brain Stimulation; Development; Diagnostic; Dyskinetic syndrome; Dystonia; Electrodes; Electromyography; Environment; Essential Tremor; Exercise; Feedback; Figs - dietary; Fingers; Foundations; Functional disorder; Gilles de la Tourette syndrome; Growth; Housing; Intervention; Involuntary Movements; Judgment; Marketing; Measures; Memory; Minor; Modeling; Modification; Monitor; Motion; Motor; Movement Disorders; Muscle Rigidity; Operating Rooms; Operative Surgical Procedures; Outcome; Outcome Assessment; Outpatients; Output; Parkinson Disease; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physiological; Procedures; Process; Quality of life; Questionnaires; Radio; Research; Resolution; Severities; Software Validation; Symptoms; System; Technology; Testing; Time; Treatment Efficacy; Tremor; Upper Extremity; Visual; Wireless Technology; Work; Wrist; base; computerized data processing; cost; data acquisition; data exchange; design; fetus cell; follow-up; improved; patient safety; programs; prototype; public health relevance; response; software development; success; tool

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.

描述（由申请人提供）：目的是设计，构建和临床评估Parkintune？，一种先进的无线运动障碍技术，以增强参与帕克森氏病（PD）的深脑刺激程序（DBS）程序的刺激程序（调音）。影响生活质量的主要PD症状包括震颤，胸肌和僵化。虽然为DBS临床成功案例燃料的确切机制尚不清楚，但在药物不再有效时，该程序已被证明可以有效缓解PD运动症状。但是，临床医生缺乏结合生理，电气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剂参数可改善减少运动症状的患者的量，并最大程度地减少并发症。评估症状的当前标准是统一的帕金森氏病评级量表（UPDRS），这是一种定性排名系统。通常在DBS电极放置手术和随后的编程课程中完成一系列练习，通常是UPDRS的上肢运动部分的一部分，以评估性能，同时临床医生定性评估症状。 Clevemed先前已经开发了一种紧凑的无线系统，以量化称为parkinsense的运动障碍症状？这种先前现有的技术将作为该建议程序的硬件平台。虽然先前的工作表现出了出色的结果，可以在临床检查中客观地量化症状，但该提出的项目将在DBS手术电极放置和刺激编程中整合几个新功能，以实时帮助。该提议的快速轨道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，可用于手术室和门诊后续的后续编程课程，以最大程度地提高患者的安全性和舒适性。在电极放置过程中传输的客观生物动力学数据和随后的编程将输入到算法中，该算法实时输出客观PD症状严重程度的连续规模，以指导临床医生的决策。 Parkintune系统的分辨率和可重复结果的改善应减少DBS程序的时间和成本，并优化患者的结果。