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

描述（由申请人提供）：目的是设计、构建和临床评估DBS-Expert，DBS-Expert是一种用于优化帕金森病（PD）等运动障碍患者脑深部电刺激（DBS）系统术后程控的专家系统。DBS-Expert将使用基于运动传感器的评估来开发用于导航程控参数空间的功能图和算法，以最大限度地提高症状获益，同时最大限度地减少副作用和电池消耗。DBS治疗脑梗死的临床应用 运动障碍如PD的治疗已经很成熟。然而，由于不同的术后管理，特别是关于DBS程控优化，DBS接受者的结局存在很大差异。大多数程控仪仅粗略了解电生理学，缺乏从数千种可能组合中确定最佳DBS参数集（接触、极性、频率、脉冲宽度和振幅）所需的专业知识或时间。DBS-Expert将消除编程中的猜测，并通过提供一个专家系统来有效确定适当的DBS设置，从而使临床医生不再负责。DBS-Expert将设计为由全科医生或护士使用，而不是由具有多年DBS程控和疾病管理经验的神经科医生或神经生理学家使用。对于首次术后程控会话，DBS-Expert将执行自动单极调查。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。刺激将在每次接触时从零开始逐渐增加，直到运动传感器单元测量到症状停止改善或出现副作用。单极测量将有助于确定电极导线部位周围的功能解剖结构，并缩小搜索空间，以确定最佳程控参数集。该治疗窗在初始术后程控会话以及所有未来调整会话中将是有价值的。在第一阶段，我们的目标是通过开发DBS程控参数空间的自动功能映射软件来证明技术可行性，并通过开发有效导航程控参数空间和输出设置的算法来证明临床可行性，这些设置和专家临床医生程控仪一样或更好地减少症状、副作用和电池使用。10名患有PD和DBS植入物的受试者将参与临床研究，其中DBS-Expert原型引导受试者完成评估，作为恒流单极审查的一部分。将开发功能图，并通过算法确定DBS设置的最佳设置。将受试者症状严重程度、副作用和电池使用情况与有经验的DBS程控仪进行比较。I期和II期开发的最终DBS专家系统将通过消除少数专家临床医生的编程负担，从而在全国范围内均衡护理，大大扩展DBS对不靠近专业中心的患者的可及性。 公共卫生相关性：脑深部电刺激（DBS）用于治疗运动障碍（如帕金森病）的临床效用已经得到了很好的确立;然而，由于术后管理不同，DBS接受者的结局存在很大差异，特别是在从数千种可能的组合中选择最佳程控参数集方面。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，以确定一组程控参数，最大限度地提高症状获益，同时最大限度地减少副作用和电池消耗。

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.