Enhancing Neuroprosthesis Performance with Nerve Cuff Electrodes

描述(申请人提供)：本项目的总体目标是将植入的神经假体在脊髓损伤(SCI)后恢复下肢功能的能力从简单的站立扩展到包括无支架的相互步进。我们将通过开发和部署专门为复合股神经和坐骨神经设计的新的神经袖带电极来实现这一点。与目前植入式功能性电刺激(FES)系统中使用的基于肌肉的电极相比，基于神经的方法具有几个明显的优势。在这次持续的研究中，我们将1)对专门为股神经近端配置的扁平界面神经电极(FINE)进行急性和慢性测试，2)展示FINE在植入神经假体中用于瘫痪后站立和行走的临床实用性，3)设计和验证用于人类坐骨神经控制脚踝运动的FINE的新配置，4)利用这些新型神经接口的束状选择性，扩展植入神经假体的能力，使其包括无支架站立和能量高效的相互步进。我们将通过我们成熟的翻译研究方法来实现这些目标，包括对周围神经束结构的定量神经解剖学研究，通过神经和肌肉骨骼建模的创新组合对电极设计进行理论优化，通过急性术中测试进行设计验证，以及慢性植入和临床表现的实验演示。在项目的这一阶段结束时，我们将建立一种新的生物启发和严格设计的神经接口的可行性，这种接口扩展了用户的功能能力，超出了现有基于肌肉的替代品目前所能实现的能力。该项目的具体目标是：1)验证为股骨近端神经设计的FING的操作，并在急性人体试验中表征其招募特性；2)确定包含股骨近端FING的神经假体的慢性临床表现，并与使用其他电极技术的历史对照进行比较；3)建立通过坐骨神经下部多接触神经袖带电极选择性激活脚踝肌肉的可行性；以及4)验证旨在控制脚踝肌肉的FING的长期操作，并在慢性人体试验中表征其临床表现。该项目的完成将代表着运动系统神经假体技术的重大进步。它将扩展目前正在进行临床试验的神经假体的功能，为现有系统用户提供立竿见影的好处，并扩大可用选项以包括步进。同样重要的是，在多束神经干周围的单个多接触袖带电极上选择性地激活个别肌肉将简化这些系统的手术安装。因此，拟议的研究继续为下肢神经假体的新开发奠定基础，同时通过我们成熟的方法将实验室的基本发现转化为慢性临床应用，使尖端技术可供瘫痪患者使用。

DESCRIPTION (provided by applicant): The overall objective of this project is to extend the capabilities of implanted neuroprostheses for restoring lower extremity function after spinal cord injury (SCI) beyond simple standing to include brace-free reciprocal stepping. We will accomplish this by developing and deploying new nerve cuff electrodes designed specifically for the compound femoral and sciatic nerves. Nerve-based approaches offer several distinct advantages over muscle-based electrodes currently utilized in implanted functional electrical stimulation (FES) systems. In this continuing investigation, we will 1) perform acute and chronic testing of the Flat Interface Nerve Electrode (FINE) configured specifically for the proximal femoral nerve, 2) demonstrate the clinical utility of the FINE in implanted neuroprostheses for standing and stepping after paralysis, 3) design and validate new configurations of the FINE for the human sciatic nerve to control ankle motion, and 4) exploit the fascicular selectivity of these new neural interfaces to extend the capabilities of the implanted neuroprosthesis to include brace-free standing and energy efficient reciprocal stepping. We will accomplish these objectives through our proven methodology for translational research consisting of quantitative neuroanatomical studies of peripheral nerve fascicular structure, theoretical optimization of electrode design via innovative combinations of neural and musculoskeletal modeling, by design validation through acute intraoperative testing, and chronic implantation and experimental demonstration of clinical performance. At the conclusion of this phase of the project we will have established the viability of a new class of biologically inspired and rigorously engineered neural interfaces that expand the functional abilities of their users beyond what is currently achievable with existing muscle-based alternatives. The Specific Aims of the project are: 1) Verify operation of the FINE designed for the proximal femoral nerve and characterize its recruitment properties in acute human trials; 2) Determine chronic clinical performance of neuroprostheses incorporating the proximal femoral FINE and compare to historical controls utilizing other electrode technologies; 3) Establish feasibility of selective activation of the ankle musculature via multicontact nerve cuff electrodes on the lower sciatic nerve; and 4) Verify the long-term operation of the FINE designed to control the ankle muscles and characterize their clinical performance in chronic human trials.Completion of this project will represent a significant advancement in the state of the art of motor system neuroprostheses. It will extend the functionality of neuroprostheses currently undergoing clinical trials, provide immediate benefit to existing system users, and expand the options available to include stepping. Just as importantly, selective activation of individual muscles from a single multi-contact cuff electrode around a multi-fascicular nerve trunk will simplify surgical installation of these systems. Thus, the proposed studies continue to build a foundation for new developments in lower extremity neuroprostheses while making cutting edge technologies available to individuals with paralysis through our proven methodology for translating fundamental discovery in the laboratory to chronic clinical application.