Phase 2 study of the NNP for Grasp and Trunk in SCI: IDEG140225-11-13-2014

第二阶段孤儿产品项目的目标是实施和评估第一个 为SCI患者提供多功能全植入式神经假体系统。本研究 代表了这些患者运动功能全身恢复的第一阶段。在 在这项研究中，我们将植入一种新型的模块化神经假体系统，“网络化”， 神经假体”（NNP），为SCI患者提供抓握、伸展和躯干功能， C5到C7运动神经节有了这个系统，我们认为受试者将重新获得控制权， 在多种功能上，包括抓握打开和关闭，头顶伸展，床移动， 坐姿稳定性和左右伸展能力。这项研究涉及的各个方面， 实施，包括植入技术、手术装置和结果 通过协调的团队方法进行评估，以最大限度地发挥 个人获得的独立性。 NNP系统是第一个完全植入的神经假体， 所有电源、信号处理、生物电位信号记录和刺激组件。这 消除了必须佩戴任何贴在皮肤上的外部部件的要求， 获得运动功能，这是所有SCI运动神经假体的要求， 约会此功能的功能含义很多：利用 在洗澡和游泳时使用神经假体，提高了控制手，手臂， 和躯干同时，在半夜使用神经假体的能力， 在没有任何穿戴辅助的情况下使用刺激功能的能力。我们预计这些 这些进步将导致神经假体的定期使用增加， 影响生活质量。

The goal of this Phase II Orphan Products project is to implement and evaluate the first multi-functional fully-implanted neuroprosthetic system for individuals with SCI. This study represents the first stage towards whole-body restoration of motor function for these patients. In this study, we will implant a novel modular neuroprosthetic system, the “Networked Neuroprosthesis” (NNP), to provide grasp, reach, and trunk function for individuals with SCI at the C5 through C7 motor level. With this system, we propose that subjects will regain control over multiple functions, including grasp opening and closing, overhead reach, bed mobility, seated posture stability, and side-to-side reach. This study involves all aspects of the implementation, including the implanted technology, the surgical installation, and the outcomes assessment through a coordinated team approach in order to maximize the functional independence gained by the individual. The NNP system is the first fully implanted neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording and stimulating components. This eliminates the requirement of having to wear any external components taped to the skin in order to gain motor function, which has been a requirement of all motor neuroprostheses for SCI to date. The functional implications of this feature is numerous: the ability to utilize the neuroprosthesis during bathing and swimming, improved ability to control both the hand, arm, and trunk simultaneously, capacity to utilize the neuroprosthesis in the middle of the night, and the ability to use the stimulated functions without any donning assistance. We expect that these advances will lead to increased regular use of the neuroprosthesis, with a subsequent positive impact on quality of life.