Multi-functional Neuroprosthetic Systems for Restoration of Motor Function

描述(申请人提供)：创伤性颈椎水平脊髓损伤可导致损伤水平以下的永久性和广泛瘫痪，导致多种身体功能的丧失，包括手、躯干和腿部运动、膀胱和肠道控制以及呼吸能力。这个项目的目标是通过一种全面的神经假体方法来恢复这些人的多种功能，以满足个人的总体需求。这种方法涉及实施的方方面面，包括植入技术、外科安装，以及通过协调的团队方法进行结果评估，以最大限度地提高个人获得的功能独立性。通过这个系统，我们打算为颈中段脊髓损伤患者提供抓握、伸展、咳嗽、床上翻转、坐姿和膀胱功能的控制。这一雄心勃勃而激动人心的目标是由于我们在过去30年中为脊髓损伤受试者研究和临床部署神经假体系统的顶峰，以及我们开发先进的神经假体。我们预计，这一系统不仅将在每个目标身体功能方面提供更多的独立性，而且将提供总体好处，以显示生活质量和健康结果的显著改善。在脊髓损伤受试者的临床可行性研究中，我们的临床研究团队展示了使用长期植入的神经假体控制双侧手功能、滚动和姿势控制、咳嗽、膀胱控制和肠道控制。每项临床研究的结果表明，每个系统都为个体提供了更多的功能独立性。然而，到目前为止，还不可能满足每个人的整体需求，并量身定做一种使所获得的功能最大化的整体方法。通过网络神经假体系统(NNPS)的开发，我们现在拥有了多功能系统的技术基础。在这个U01项目中采用的策略是最终确定我们建议的整体神经假体方法的关键组件。因此，该方法的每个组成部分，包括技术、监管批准、手术安装、结果评估和整体实施，将在本项目期间完成，最终在脊髓损伤受试者中实施多功能NNPS。这个项目的最终结果是，我们将展示使用先进的神经假体系统结合精简和连贯的实施战略解决严重残疾个人多种残疾的可行性。 公共卫生相关性 我们提出的多功能神经假体对残疾人健康的影响是显著的。颈椎水平脊髓损伤的患者应该能够恢复双手握力和伸手的功能，恢复坐姿的稳定性，恢复在床上翻滚的能力，恢复产生生产性咳嗽的能力，恢复膀胱功能和恢复肠道功能。

DESCRIPTION (provided by applicant): Traumatic cervical-level spinal cord injury can result in permanent and extensive paralysis below the level of injury, causing the loss of multiple body functions, including hand, trunk and leg movement, bladder and bowel control, and respiratory capacity. The goal of this project is to restore these multiple functions to these individuals through a comprehensive neuroprosthetic approach that addresses the overall needs of the individual. This approach 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. With this system, we intend to provide individuals who have a mid-cervical level spinal cord injury with control over grasp, reach, cough, turning in bed, seated posture, and bladder function. This ambitious and exciting goal is made possible by the culmination of our research and clinical deployment of neuroprosthetic systems for spinal cord injured subjects over the past 30 years and our development of an advanced neuroprosthesis. We anticipate that this system will not only provide increased independence in each of the targeted body functions, but will provide an overall benefit to demonstrate significant improvements in quality of life and health outcomes. In clinical feasibility studies with spinal cord injured subjects, our clinical research teams have demonstrated the control of bilateral hand function, rolling and postural control, cough, bladder control and bowel control using chronically implanted neuroprostheses. Outcomes from each clinical study demonstrate that each system provides increased functional independence to the individual. However, to this point, it has not been possible to address each individual's holistic needs and tailor an overall approach that maximizes the function gained. Through the development of a Networked Neuroprosthetic System (NNPS), we now have the technological foundation for a multi-functional system. The strategy employed in this U01 project is to finalize the key components of our proposed holistic neuroprosthetic approach. Thus, each component of the approach, including the technology, regulatory approvals, surgical installation, outcome assessment and overall implementation, will be brought to completion during this project, culminating in the implementation of the multi-function NNPS in spinal cord injured subjects. The ultimate outcome of this project is that we will demonstrate the feasibility of addressing multiple disabilities in severely disabled individuals using an advanced neuroprosthetic system coupled with a streamlined and cohesive implementation strategy. PUBLIC HEALTH RELEVANCE The impact on the health of disabled individuals of our proposed multi-function neuroprosthesis is signficant. Individuals with cervical-level spinal cord injury should be able to regain the use of the hands for grasp and reaching, regain seating stability, regain the ability to roll over in bed, regain the ability to generate a productive cough, regain bladder function and regain bowel function.