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 用于脊髓损伤患者的多功能全植入神经假体系统。本研究 代表着这些患者走向全身运动功能恢复的第一阶段。在……里面 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 神经假体“(NNP)，为脊髓损伤患者提供抓握、伸展和躯干功能 C5至C7马达级别。有了这个系统，我们提出受试者将重新获得控制权 多种功能，包括抓取打开和关闭，头顶伸展，床活动， 坐姿稳定，侧身伸展。这项研究涉及到了 实施，包括植入技术、手术安装和结果 通过协调的团队方法进行评估，以最大限度地提高功能 个人获得的独立。 NNP系统是第一个完全植入的神经假体，包括植入 所有电源、信号处理、生物电势信号记录和刺激组件。这 消除了必须按顺序佩戴任何贴在皮肤上的外部组件的要求 以获得运动功能，这一直是所有运动神经假体对脊髓损伤的要求 约会。此功能的功能含义很多：能够利用 在洗澡和游泳时使用神经假体，提高了控制手，手臂， 和躯干同时进行，半夜使用神经假体的能力，以及 能够在没有任何穿戴帮助的情况下使用刺激功能。我们预计这些 进展将导致神经假体的常规使用增加，随后将出现积极的结果 对生活质量的影响。

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.