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: 7537817
• 负责人: JOSEPH P GIUFFRIDA
• 金额: $ 24.56万
• 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 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7537817
• 关键词: Adverse effects; Affect; Algorithms; Ambulatory Surgical Procedures; Amplifiers; Behavioral; Biomedical Engineering; Bradykinesia; 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; Placement; Procedures; Process; Public Health; Quality of life; Questionnaires; Radio; Rate; Research; Resolution; Score; Severities; Software Validation; Standards of Weights and Measures; Symptoms; System; Technology; Testing; Time; Transplantation; Treatment Efficacy; Tremor; United States Food and Drug Administration; Upper Extremity; Visual; Wireless Technology; Work; Wrist; base; computerized data processing; cost; data acquisition; design; fetus cell; follow-up; improved; patient safety; programs; prototype; response; software development; success; tool; transmission process

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.

描述（由申请人提供）：目的是设计、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，用于增强帕金森病（PD）脑深部电刺激（DBS）手术中涉及的刺激程控（调谐）。影响生活质量的主要PD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，但该程序已被证明在药物不再有效时有效缓解PD运动症状。然而，临床医生缺乏结合联合收割机生理、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器参数可改善患者接受的运动症状减轻量，并最大限度地减少并发症。目前评估症状的标准是统一帕金森病评定量表（Unified Parkinson's Disease Rating Scale，简称EADS），这是一种定性评级系统。在DBS电极放置手术和后续程控会话期间，通常会完成一系列练习（通常是DBS上肢运动部分的子集），以在临床医生定性评估症状的同时评价性能。CleveMed先前开发了一种紧凑的无线系统，用于量化运动障碍症状，称为ParkinSense。这一先前存在的技术将作为这一拟议计划的硬件平台。虽然之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，但该拟议项目将集成几个新功能，用于DBS手术电极放置和刺激编程的实时辅助。由该拟议快速通道应用程序产生的临床可部署ParkinTune系统将提供一种紧凑的无线系统，用于手术室和门诊随访程控会话，最大限度地提高患者安全性和舒适度。电极放置和后续编程期间传输的客观生物动力学数据将输入到算法中，该算法实时输出客观PD症状严重程度的连续量表，以指导临床医生决策。ParkinTune系统的分辨率提高和可重复结果应可减少DBS手术的时间和成本，并优化患者结果。公共卫生相关性。 虽然促进脑深部电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，该程序可有效缓解帕金森病的运动症状。然而，临床医生缺乏结合联合收割机生理、电气和行为数据来优化电极放置和刺激器编程的工具。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辅助刺激编程，以优化患者结局并减少相关时间和成本。