Intracortical control of FES-restored arm and hand function in people with SCI

该项目将恢复手臂和手功能的个人完全瘫痪使用功能性电 刺激（FES）将使这些人能够有效地指挥这些运动， 使用皮质内脑机接口（BMI）的直观方式。我们将使用经皮接口， FES和BMI组件，以实现全功能但也是可逆的BMI命令的FES 系统这是最终实现永久性植入BMI控制的下一步。 FES系统。将植入5名高度（C1-C4）脊髓损伤患者的麻痹肌肉 利用FES电极来恢复手臂和手的多个运动足以进行有意义的多关节， 功能活动。在相同的个体中，96通道皮质内阵列（“BrainGate 2”）将被植入到 初级运动皮层的手臂/手部区域，并且由此产生的信号将用于命令 参与者的手臂和手通过“思想”。拟议系统的主要组成部分是：肌内 带经皮电极导线的电极（Ardiem Medical）、体外刺激器（FES Center）、BrainGate 2 皮质内阵列和相关的外部硬件（Blackrock Microsystems的Neuroport），以及标准 具有实时操作系统（Matlab xPC Target）的计算机作为FES控制器。参与者将被 强烈的动机，以优化性能的一个功能齐全的系统，驱动自己的瘫痪 他们将有充分的机会练习和学习界面。我们将测试对照组 三种不同的命令界面的性能，已广泛用于类似的应用程序：（1） 连续轨迹控制在以往BMI研究中被广泛采用;（2）基于运动目标的控制被广泛采用 用于控制机器人手臂，和（3）基于状态的“门控斜坡”控制广泛用于控制人工 假肢参与者将进行相同的标准动作以及功能活动 每个接口。我们将比较每种指挥方法的有效性和鲁棒性， 技术和功能性能指标（准确性、速度、随时间的一致性、功能性能， 易用性）。我们还将评估M1生成连续、目标和状态命令的能力， 在使用这三种方法的同时，表征神经信号特性（调谐和调制深度）的变化 接口。该项目将首次直接测试人类皮质内BMI控制的可行性。 因此，我们的研究结果将指导未来完全植入BMI系统的规格。我们 团队在开发和测试上肢FES系统方面拥有30多年的经验，包括在患有 手臂完全瘫痪在过去的7年里，我们一直致力于开发人类皮质内BMI， 获得监管机构的全面批准，并在克利夫兰建立了一个临床BrainGate 2站点。这个项目是一个自然的 通过结合FES和BMI方法扩展了我们过去在SCI患者中的工作。技术风险 该项目的投资回报率相对较低，但潜在的科学和恢复回报率很高。

This project will restore arm and hand function to individuals with complete paralysis using functional electrical stimulation (FES) AND will give these people the ability to command these movements in an effective and intuitive way using an intracortical brain-machine interface (BMI). We will use percutaneous interfaces for both the FES and BMI components to implement a fully functional but also reversible BMI-commanded FES system. This is the immediate next step in the ultimate realization of a permanently implanted BMI-controlled FES system. Paralyzed muscles of 5 individuals with high level (C1-C4) spinal cord injuries will be implanted with FES electrodes to restore multiple motions of the arm and hand sufficient for meaningful multi-joint, functional activities. In the same individuals, a 96-channel intracortical array ("BrainGate2") will be implanted in the arm/hand area of primary motor cortex, and the resulting signals will be used to command the motions of the participant's arm and hand via "thought". The main components of the proposed system are: intramuscular electrodes with percutaneous leads (Ardiem Medical), an external stimulator (FES Center), a BrainGate2 intracortical array and associated external hardware (Neuroport by Blackrock Microsystems), and a standard computer with a real-time operating system (Matlab xPC Target) as the FES controller. Participants will be strongly motivated to optimize the performance of a fully functional system that drives their own paralyzed arms, and they will be given ample opportunity to practice and learn the interfaces. We will test the control performance for three different command interfaces that have been widely used in similar applications: (1) continuous trajectory control used widely in previous BMI research, (2) movement goal-based control widely used to control robotic arms, and (3) state-based "gated ramp" control used widely to control artificial prosthetic arms. Participants will perform the same set of standard movements as well as functional activities with each interface. We will compare the effectiveness and robustness of each command approach based on technical and functional performance metrics (accuracy, speed, consistency over time, functional performance, ease of use). We will also evaluate the ability of M1 to generate continuous, goal and state commands, and will characterize changes in neural signal properties (tuning and modulation depth) while using these three interfaces. This project will, for the first time, directly test the feasibility of a human intracortical BMI-controlled FES upper limb system, so our results will guide the specifications of future, fully-implanted BMI systems. Our team has 30+ years of experience in developing and testing upper limb FES systems, including in people with complete arm paralysis. We have been working to develop a human intracortical BMI for the past 7 years, have full regulatory approval, and have established a clinical BrainGate2 site in Cleveland. This project is a natural expansion of our past work by combining the FES and BMI approaches in people with SCI. The technical risks of this project are relatively low, but the potential scientific and rehabilitation returns are very high.