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.

其目标是设计、构建和临床评估一种先进的无线运动“ParkinTune 用于增强深部脑刺激中涉及的刺激编程（调谐）的障碍监测技术 (DBS)帕金森病（PD）的治疗方法。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刺激DBS临床成功故事的确切机制 目前尚不清楚，该程序已被证明可以有效地缓解PD运动症状时，药物治疗 不再有效。然而，临床医生缺乏结合联合收割机生理，电气和行为的工具， 优化电极放置和刺激器编程的数据。优化电极放置， 刺激器参数改善了患者接受的运动症状减轻量， 并发症目前评估症状的标准是统一帕金森病评级 量表（英语：Scale），一种定性排名系统。一系列的练习，通常是上半场的一个子集， 在DBS电极放置手术期间，通常会完成肢体运动部分， 随后的程控会话以评价性能，同时临床医生定性评估 症状CleveMed此前已经开发出一种紧凑的无线系统来量化运动障碍 帕金森病的症状”。这项先前存在的技术将作为硬件平台， 这个提议的方案。虽然以前的工作已经显示出客观量化症状的出色结果， 在临床检查期间，该拟议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程控。可在临床上部署的ParkinTune 从所提出的快速通道应用中得到的系统将提供一种紧凑的无线系统， 手术室和门诊随访程控会话，最大限度地提高患者安全性， 令人担心电极放置和后续程控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， 指导临床医生决策。ParkinTune系统的分辨率和可重复结果得到提高 应减少DBS手术的时间和成本，并优化患者结局。