DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping

描述(由申请人提供)：目标是设计、构建和临床评估DBS-Expert，这是一个优化帕金森氏病(PD)等运动障碍患者脑深部刺激(DBS)系统术后编程的专家系统。DBS-Expert将使用基于运动传感器的评估来开发功能图和算法，以导航编程参数空间，最大限度地提高症状益处，同时将副作用和电池消耗降至最低。DBS在临床上的应用价值 运动障碍的治疗，如帕金森病，已经得到很好的证实。然而，由于不同的术后处理，尤其是DBS程序的优化，DBS接受者之间的结果有很大的差异。大多数程序员对电生理学只有粗略的了解，缺乏从数千种可能的组合中确定一组最佳DBS参数(接触、极性、频率、脉冲宽度和幅度)所需的专业知识或时间。DBS-Expert将通过提供一个有效确定适当DBS设置的专家系统，从编程中消除猜测工作，并将责任从临床医生手中移开。DBS-Expert将设计为供全科医生或护士使用，而不是由在DBS编程和疾病管理方面拥有多年经验的神经科医生或神经生理学家使用。对于术后的第一次编程，DBS-Expert将执行自动单极测量。患者将佩戴我们现有的运动传感器装置，并在各种DBS设置下进行运动评估。每次接触时，刺激将从零开始递增，直到由运动传感器单元测量的症状停止改善或出现副作用。单极测量将有助于确定导联部位周围的功能解剖结构，并缩小搜索空间，以确定最佳编程参数集。这一治疗窗口在最初的术后计划阶段以及未来的所有调整阶段都将是有价值的。在第一阶段，我们的目标是通过开发用于DBS编程参数空间和临床可行性的自动功能映射的软件来展示技术可行性，通过开发算法来高效地导航编程参数空间和输出设置，以减少症状、副作用和电池使用，或者比专业临床医生程序员更好。10名帕金森病患者和DBS植入者将参与一项临床研究，在该研究中，DBS专家原型将指导受试者通过评估，作为恒流单极审查的一部分。将开发一张功能图，算法将确定一组最佳的DBS设置。受试者的症状严重程度、副作用和电池使用情况将与经验丰富的DBS程序员进行比较。第一阶段和第二阶段开发的最终DBS专家系统将通过消除少数专家临床医生的编程负担，极大地扩大DBS对不在专门中心附近的患者的可及性，从而在全国范围内实现医疗均等化。 公共卫生相关性：脑深部刺激(DBS)用于治疗运动障碍(如帕金森氏病)的临床效用已经得到很好的证实；然而，由于不同的术后处理，特别是在从数千种可能的组合中选择一组最佳编程参数方面，DBS的接受者之间的结果存在巨大差异。拟议的系统将使用基于运动传感器的评估来开发功能图和算法，以确定一组编程参数，使症状益处最大化，同时将副作用和电池消耗降至最低。

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess DBS-Expert, an expert system for optimizing the postoperative programming of deep brain stimulation (DBS) systems in patients with movement disorders such as Parkinson's disease (PD). DBS-Expert will use motion sensor based assessments to develop a functional map and algorithms for navigating the programming parameter space that maximize symptomatic benefits while minimizing side effects and battery consumption. The clinical utility of DBS for the treatment of movement disorders such as PD is well been established. However, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning DBS programming optimization. Most programmers have only a cursory understanding of electrophysiology and lack the expertise or time required to determine an optimal set of DBS parameters (contact, polarity, frequency, pulse width, and amplitude) out of the thousands of possible combinations. DBS-Expert will remove the guesswork from programming and take the responsibility out of the hands of the clinicians by providing an expert system that efficiently determines appropriate DBS settings. DBS-Expert will be designed for use by a general practitioner or nurse rather than by a neurologist or neurophysiologist with years of experience in DBS programming and disease management. For the first postoperative programming session, the DBS-Expert will perform an automated monopolar survey. The patient will wear our existing motion sensor unit and perform motor assessments at various DBS settings. Stimulation will be incrementally increased from zero at each contact until symptoms stop improving as measured by a motion sensor unit or side effects appear. The monopolar survey will help determine the functional anatomy around the lead site and narrow the search space for determining an optimal set of programming parameters. This therapeutic window will be valuable at the initial postoperative programming session as well as all future adjustment sessions. In Phase I, we aim to demonstrate technical feasibility by developing software for automated functional mapping of the DBS programming parameter space and clinical feasibility by developing algorithms that efficiently navigate the programming parameter space and output settings that reduce symptoms, side effects, and battery usage as well or better than would an expert clinician programmer. Ten subjects with PD and a DBS implant will participate in a clinical study in which the DBS-Expert prototype guides the subjects through assessments as part of a constant-current monopolar review. A functional map will be developed and algorithms will determine an optimal set of DBS settings. Subject symptom severities, side effects, and battery usage will be compared to that of an experience DBS programmer. The final DBS-Expert system resulting from Phase I and II development will greatly expand the accessibility of DBS for patients not located near specialized centers by removing the programming burden from a few expert clinicians thereby equalizing care across the country. PUBLIC HEALTH RELEVANCE: The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. The proposed system will use motion sensor based assessments to develop a functional map and algorithms to determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.