Enhanced Modular Neuroprosthesis for the Restoration of Function in Neurological Injury or Disease

由于神经损伤或疾病而导致的运动功能丧失， 独立、健康、参与社会和生活质量。神经系统疾病如中风， 脑性麻痹（CP）、脊髓损伤（SCI）和多发性硬化（MS）可导致活动能力丧失， 在日常活动中严重丧失独立性。在许多这些疾病中，运动系统仍然存在 但皮层对这些功能的控制丧失了。恢复这些个体功能的一种方法 是使用电刺激周围神经，称为神经假体， 协调控制瘫痪的肌肉。为了满足这一患者群体的需求， 凯斯西储最近发明并开发了一种新的神经假体概念 大学（CWRU）。这种神经假体是"网络化神经假体"（NNP），并使用模块化的 植入器械的方法。NNP系统是第一个完全植入的组配式神经假体， 包括植入所有电源、信号处理、生物电位信号记录和刺激 件. NNP系统的模块化设计使其能够根据需要进行配置和定制 每一种残疾类型和每一个残疾人，以便最大限度地利用 个体剩余的自主功能，根据需要提供电刺激功能。一个主要 我们项目的一个里程碑是在第一例受试者中植入了NNP。我们现在 寻求推进技术以影响更广泛的患者群体，改善用户访问 技术，并使技术转移到现实世界的临床环境。实现这些 目标，我们的具体目标是1）增强硬件，特别是通过改进电源管理 2）改进软件，重点是向多个地点转让这一技术; 3） 构建完整的系统，以及4）全面测试所有组件，为监管部门的批准做准备。 所有拟议变更将作为对当前设计的修改提交给FDA， 在进入临床试验之前，将寻求适当的监管批准。于年底 根据该提案，我们将完成NNP系统的全面升级，大大扩展临床适应症 整个系统的可用性。这项工作最终将提交一份早期可行性IDE， SCI的临床实施，为未来的研究建立了一个滩头阵地。

The loss of motor function due to neurological injury or disease has significant consequences on independence, health, participation in society, and quality of life. Neurological disorders such as stroke, cerebral palsy (CP), spinal cord injury (SCI) and multiple sclerosis (MS) can lead to loss of mobility and significant loss of independence in daily activities. In many of these diseases, the motor system remains intact but cortical control over these functions is lost. One method of restoring function to these individuals is the use of electrical stimulation of the peripheral nerves, known as neuroprostheses, to restore coordinated control of the paralyzed muscles. In order to address the needs of this patient population, a new concept in neuroprostheses has recently been invented and developed at Case Western Reserve University (CWRU). This neuroprosthesis is the “Networked Neuroprosthesis” (NNP), and uses a modular approach to implanted devices. The NNP system is the first fully implanted modular neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording, and stimulating components. The modular design of the NNP System allows it to be configured and tailored for the needs of each type of disability and each individual with a disability so that maximum use is made of the individual's remaining voluntary function, with electrically-stimulated function provided as needed. A major milestone of our program that has been achieved is the implantation of the NNP in the first subject. We now seek to advance the technology to impact a broader patient population, improve users to access the technology, and enable the transfer of the technology to the real-world clinical setting. To achieve these goals, our Specific Aims are to 1) enhance the hardware, particularly through improved power management and circuit upgrades; 2) improve software, with a focus on transfer of this technology to multiple sites; 3) build completed systems, and 4) fully test all components in preparation for regulatory approval. All proposed changes will be introduced to the FDA as modifications to the current design, and appropriate regulatory approvals will be sought prior to advancing to clinical trials. At the end of this proposal, we will have completed the full upgrade of the NNP System, greatly expanding clinical indications and usability of the entire system. This work will culminate in the submission of an Early Feasibility IDE for clinical implementation in SCI, establishing a beachhead for future studies.