Enhancing Neuroprosthesis Performance with Nerve Cuff Electrodes

描述（由申请人提供）：本项目的总体目标是扩展植入的神经假体在脊髓损伤（SCI）后恢复下肢功能的能力，使其超越简单站立，包括无支架的往复踏步。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神经袖带电极来实现这一目标。基于神经的方法提供了几个明显的优势，目前在植入式功能性电刺激（FES）系统中使用的基于肌肉的电极。在这项持续研究中，我们将1）对专门为近端股神经配置的扁平界面神经电极（FINE）进行急性和慢性测试，2）证明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）设计和确认FINE用于人类坐骨神经控制踝关节运动的新配置，以及4）利用这些新神经接口的神经束选择性来扩展植入的神经假体的能力，以包括无支架站立和能量有效的往复步进。我们将通过我们经过验证的转化研究方法来实现这些目标，包括外周神经分支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性能的实验证明。在项目的这一阶段结束时，我们将建立一类新的生物启发和严格设计的神经接口的可行性，这些接口扩展了用户的功能能力，超出了现有的基于肌肉的替代品。该项目的具体目的是：1）验证为股骨近端神经设计的FINE的操作，并在急性人体试验中表征其募集特性; 2）确定包含股骨近端FINE的神经假体的长期临床性能，并与使用其他电极技术的历史对照进行比较; 3）建立通过多触点神经袖状电极在下坐骨神经上选择性激活踝部肌肉组织的可行性;以及4）验证设计用于控制踝关节肌肉的FINE的长期操作，并在慢性人体试验中表征其临床性能。该项目的完成将代表运动系统神经假体技术水平的重大进步。它将扩展目前正在进行临床试验的神经假体的功能，为现有的系统用户提供直接的好处，并扩展可用的选项，包括步进。同样重要的是，从多束神经干周围的单个多触点袖带电极选择性激活单个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发展奠定基础，同时通过我们将实验室中的基本发现转化为长期临床应用的成熟方法，为瘫痪患者提供尖端技术。

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.