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

该项目将使用功能电技术恢复完全瘫痪患者的手臂和手功能 刺激(FES)，并将使这些人有能力在有效和 使用皮质内脑机接口(BMI)的直观方式。我们将对这两种情况使用经皮界面 FES和BMI组件，以实现全功能但也可逆转的BMI命令的FES 系统。这是最终实现永久植入BMI控制的下一步 FES系统。5例高度脊髓损伤患者的瘫痪肌肉将被植入 利用FeS电极恢复手臂和手的多种运动，足以进行有意义的多关节， 功能性活动。在相同的个体中，一个96通道的皮质内阵列(“BrainGate2”)将被植入 初级运动皮质的手臂/手部区域，以及由此产生的信号将被用来指挥 参与者的手臂和手通过“思想”。建议的系统的主要组成部分是：肌肉内 经皮电极(Ardiem Medical)、外部刺激器(FES Center)、BrainGate2 皮质内阵列和相关外部硬件(BlackRock MicroSystems的Neuroport)，以及标准 使用实时操作系统(MatLab XPC Target)作为FES控制器的计算机。参与者将是 强烈的动力来优化一个功能齐全的系统的性能，使自己陷入瘫痪 他们将有足够的机会练习和学习界面。我们将测试该控件 在类似应用中广泛使用的三种不同命令界面的性能：(1) 连续轨迹控制在以往的BMI研究中得到了广泛的应用。(2)广泛的基于运动目标的控制 用于控制机械臂；(3)基于状态的“门控坡道”控制广泛用于控制人工机械臂。 义肢。参与者将表演一套相同的标准动作和功能活动 使用每个接口。我们将基于以下方面比较每种命令方法的有效性和健壮性 技术和功能性能指标(准确性、速度、随时间变化的一致性、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，并将 描述使用这三种方法时神经信号特性(调谐和调制深度)的变化 接口。该项目将首次直接测试人类大脑皮质内体重指数控制的可行性 FES上肢系统，因此我们的结果将指导未来全面植入的BMI系统的规格。我们的 团队在开发和测试上肢FES系统方面有30年的经验，包括对患有 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，已经 完全获得监管部门的批准，并在克利夫兰建立了一个临床BrainGate2网站。这个项目是自然而然的 通过在脊髓损伤患者中结合FES和BMI方法来扩展我们过去的工作。技术风险 这个项目的回报率相对较低，但潜在的科学和康复回报非常高。

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.