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: 7934369
• 负责人: JOSEPH P GIUFFRIDA
• 金额: $ 13.94万
• 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/7934369
• 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; response; software development; success; tool

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.

目标是设计、构建和临床评估 ParkinTune”，这是一种先进的无线运动 紊乱监测技术可增强深部脑刺激中涉及的刺激编程（调谐） (DBS) 治疗帕金森病 (PD) 的手术。影响生活质量的主要 PD 症状包括 震颤、运动迟缓和强直。虽然推动 DBS 临床成功故事的确切机制 仍不清楚，该程序已被证明可以有效缓解药物治疗时的帕金森病运动症状 不再有效。然而，临床医生缺乏结合生理、电和行为的工具 用于优化电极放置和刺激器编程的数据。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，并将其最小化 并发症。目前评估症状的标准是统一帕金森病评级 量表（UPDRS），一种定性排名系统。一组练习，通常是上部练习的子集 UPDRS 的肢体运动部分通常在 DBS 电极放置手术期间完成， 随后的编程会议来评估表现，同时临床医生进行定性评估 症状。 CleveMed 此前开发了一种紧凑型无线系统来量化运动障碍 这种症状被称为“ParkinSense”。这项先前存在的技术将作为硬件平台 这个拟议的计划。虽然之前的工作在客观量化症状方面取得了出色的成果 在临床检查期间，该拟议项目将集成几个新功能，以提供实时帮助 DBS 手术电极放置和刺激编程。可临床部署的 ParkinTune 由该提议的快速通道应用产生的系统将提供一个紧凑的无线系统，用于 手术室和门诊后续编程课程可最大限度地提高患者安全和 舒适。在电极放置和后续编程过程中传输的客观生物动力学数据 将被输入算法，实时输出连续的客观 PD 症状严重程度 指导临床医生决策。 ParkinTune 系统的改进分辨率和可重复结果 应减少 DBS 手术的时间和成本，并优化患者的治疗效果。