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

用于恢复神经损伤或疾病功能的增强型模块化神经假体

• 批准号: 9361985
• 负责人: KEVIN L. KILGORE
• 金额: $ 71.32万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-06 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9361985
• 关键词: Achievement; Address; Bathing; Cerebral Palsy; Cervical; Clinical; Clinical Trials; Computer software; Dependence; Development; Devices; Disease; Electric Stimulation; Electromagnetics; Electrostatics; Family Caregiver; Foundations; Funding; Future; Goals; Health; Home environment; Implant; Individual; Injury; Investigation; Lead; Magnetic Resonance Imaging; Methods; Microprocessor; Modification; Motion; Motor; Movement; Multiple Sclerosis; Muscle; Nervous System Trauma; Operating System; Operative Surgical Procedures; Paralysed; Patients; Pattern; Peripheral Nerve Stimulation; Preparation; Quality of life; Rehabilitation therapy; Research; Research Personnel; Running; Safety; Signal Transduction; Site; Societies; Spinal cord injury; Stroke; Swimming; System; Target Populations; Technology; Technology Transfer; Testing; Time; United States Food and Drug Administration; Universities; Work; clinical application; design; disability; functional restoration; grasp; human subject; implantable device; implantation; improved; loss of function; nervous system disorder; neuroprosthesis; operation; patient population; programs; research and development; restoration; signal processing; software development; usability

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.

由于神经损伤或疾病而导致的运动功能丧失会对人产生重大影响 独立、健康、参与社会和生活质量。神经系统疾病，如中风、 脑瘫 (CP)、脊髓损伤 (SCI) 和多发性硬化症 (MS) 可导致活动能力丧失和 日常活动的独立性显着丧失。在许多此类疾病中，运动系统仍然存在 完好无损，但皮层对这些功能的控制丧失了。恢复这些人功能的一种方法 是使用周围神经的电刺激（称为神经假体）来恢复 协调控制瘫痪的肌肉。为了满足该患者群体的需求， 凯斯西储大学最近发明并开发了神经假体的新概念 大学（CWRU）。这种神经假体是“网络神经假体”（NNP），并使用模块化 植入设备的方法。 NNP 系统是第一个完全植入的模块化神经假体 包括所有电源的植入、信号处理、生物电信号记录和刺激 成分。 NNP 系统的模块化设计使其能够根据需要进行配置和定制 每种类型的残疾和每个残疾人，以便最大限度地利用 个人剩余的自愿功能，并根据需要提供电刺激功能。一个专业 我们已实现的计划的里程碑是在第一个受试者中植入 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，并使技术能够转移到现实世界的临床环境中。为了实现这些 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 和电路升级； 2）改进软件，重点是将这项技术转移到多个站点； 3） 构建完整的系统，4) 全面测试所有组件，为监管部门批准做好准备。 所有提议的变更都将作为对当前设计的修改提交给 FDA，并且 在进入临床试验之前，将寻求适当的监管批准。在这最后 根据提案，我们将完成NNP系统的全面升级，大大拓展临床适应症 以及整个系统的可用性。这项工作最终将提交一个早期可行性 IDE SCI临床实施，为未来研究奠定滩头阵地。