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、建造和临床评估ParkinTune，这是一种先进的无线运动 用于增强脑深部刺激的刺激编程(调谐)的紊乱监测技术 (DBS)帕金森氏病(PD)手术。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。虽然推动星展银行临床成功故事的确切机制 目前尚不清楚，该程序已被证明能有效缓解帕金森病患者的运动症状 已经不再有效了。然而，临床医生缺乏将生理、电和行为相结合的工具 用于优化电极放置和刺激器编程的数据。优化电极放置和 刺激器参数改善患者获得的运动症状减轻量并将其降至最低 并发症。目前评估症状的标准是统一的帕金森氏病分级 量表(UPDRS)，一个定性的排名系统。一组练习，通常是上半身的一部分 UPDRS的肢体运动部分通常在DBS电极放置手术期间完成，并 在临床医生进行定性评估的同时评估性能的后续编程会话 症状。CleveMed之前开发了一种紧凑型无线系统来量化运动障碍 症状称为帕金森。这项先前存在的技术将作为 这项拟议的计划。虽然以前的工作已经显示了客观量化症状的出色结果 在临床检查期间，这个提议的项目将集成几个新功能，以实时帮助 DBS手术电极放置和刺激编程。临床可展开的ParkinTune 由该提议的Fast-Track应用产生的系统将提供紧凑的无线系统用于 手术室和门诊的后续计划会议，最大限度地提高患者的安全和 舒适。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，该算法实时输出目标PD症状严重程度的连续等级，以 指导临床医生决策。ParkinTune系统分辨率的提高和重复性结果 应减少DBS手术的时间和成本，并优化患者结果。