Peripheral Nerve Implementation of Functional Neuroprostheses

描述（由申请人提供）：上肢FES系统已帮助数百名颈段（即C3-C6）SCI患者使用双手，提高了他们的独立性和生活质量。这些系统依赖于基于肌肉的电极，特别是对于手的功能。外周神经电极已在动物中进行了广泛的测试，并证明了选择性刺激和安全性。与基于肌肉的电极相比，外周神经电极提供了几个潜在的优势，包括完整的肌肉募集、单个植入物的多种功能、与肌肉的机械隔离、较低的刺激功率要求以及无活动依赖性募集。这项工作的长期目标是在几种神经假体应用中实现高度选择性的神经袖带电极，特别是平面界面神经电极（FINE）。本提案旨在评估FINE在上肢应用中的可行性。评估可行性的关键步骤是收集上肢神经分支解剖结构的定量测量，选择最佳植入位置，选择最佳电极设计，并在术中证明这些电极刺激的选择性。该提案包括三个具体目标。1)生成人体上肢神经的定量解剖数据。有大量关于上肢神经定性解剖的文献，但设计电极尺寸和创建计算机模拟以预测电极性能所需的定量数据很少。2)建立上肢神经生物力学模型。一旦定量解剖结构可用，有限元方法（FEM）模型可以预测袖带电极刺激的募集。这提供了在患者实施之前优化电极设计的工具。3)在术中试验中证明神经套管的性能。一旦通过计算机模型设计和测试了电极，对其能力的唯一真正测试就是在人体上进行测试。先前的研究表明，术中刺激选择性的测量是慢性选择性的良好预测因子。因此，急性术中测试可以证明周围神经刺激是否适用于上肢神经假体系统。在拟议的工作完成后，我们希望有所有必要的数据表明，全神经袖带系统可以永久植入患者，以恢复上肢功能的中，高颈椎脊髓损伤患者。我们预计这项工作将在上肢FES应用中产生重大影响，并为其他应用铺平道路，例如截肢者假肢的神经接口。

DESCRIPTION (provided by applicant): Upper extremity FES systems have assisted hundreds of individuals with cervical-level (i.e. C3-C6) SCI to use their hands and increase their independence and quality of life. These systems have relied on muscle-based electrodes, especially for the functions of the hand. Peripheral nerve electrodes have been extensively tested in animals and demonstrated selective stimulation and safety. Peripheral nerve electrodes offer several potential advantages compared to muscle-based electrodes, including complete muscle recruitment, multiple functions from a single implant, mechanical isolation from the muscle, lower stimulation power requirements, and no activitydependent recruitment. The long-term goal of this work is to implement highly selective, extraneural cuff electrodes, specifically the flat interface nerve electrode (FINE) in several neuroprosthesis applications. This purpose of this proposal is to assess the feasibility of using the FINE in upper extremity applications. The key steps in assessing feasibility are to collect quantitative measures of the fascicular anatomy of the upper extremity nerves, to select optimal implant locations, to select optimal electrode designs, and to demonstration intraoperatively the selectivity of stimulation with these electrodes. The proposal consists of three specific aims. 1) Generate quantitative anatomical data of the human upper extremity nerves. There is extensive literature on the qualitative anatomy of the upper extremity nerves, but little quantitative data required to design electrode sizes and create computer simulations for prediction electrode performance. 2) Develop neurobiomechanical models of upper extremities. Once the quantitative anatomy is available, finite element method (FEM) models can predict recruitment with cuff electrode stimulation. This provides a tool to optimize the electrode design prior to patient implementation. 3) Demonstrate nerve cuff performance in intraoperative trials. Once an electrode is designed and tested via computer models, the only true test of its capabilities is by testing in humans. Previous studies have shown that intraoperative measures of stimulation selectivity are good predictors of chronic selectivity. Therefore, acute, intraoperative testing can demonstrate whether or not the peripheral nerve stimulation is appropriate for upper extremity neuroprostheses systems. At the completion of the proposed work, we expect to have all the necessary data to show that an all-nerve cuff system can be permanently implanted in a patient to restore upper extremity function in mid- to high-cervical level SCI patients. We expect this work will make a significant impact in upper extremity FES applications and pave the path to other applications, such as neural interfaces for amputee prosthetics.