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

FES 恢复 SCI 患者手臂和手功能的皮质内控制

• 批准号: 8697643
• 负责人: Robert F. Kirsch
• 金额: $ 68.95万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8697643
• 关键词: Algorithms; Amplifiers; Area; Attention; Brain; Cervical; Clinical; Cognitive; Computers; Disabled Persons; Effectiveness; Elbow; Electric Stimulation; Electrical Stimulation of the Brain; Electrodes; Eye Movements; Face; Feedback; Forearm; Future; Goals; Hand; Hand functions; Human; Implant; Implanted Electrodes; Individual; Institutional Review Boards; Intramuscular; Joints; Lateral; Learning; Medical; Medical center; Metric; Motion; Motor Cortex; Movement; Muscle; Neck; Operating System; Oral cavity; Outpatients; Paralysed; Participant; Pattern; Performance; Persons; Physicians; Procedures; Property; Prosthesis; Proxy; Quadriplegia; Ramp; Recruitment Activity; Rehabilitation therapy; Research; Risk; Robotics; Rotation; Safety; Shoulder; Signal Transduction; Site; Speed; Spinal cord injury; Staging; Sterile coverings; System; Testing; Time; Tongue; Training; Upper Extremity; Voice; Work; arm; base; brain machine interface; compare effectiveness; computer generated; experience; grasp; hand grasp; improved; microsystems; preference; public health relevance; rehearsal; relating to nervous system; screening; sensor; signal processing; virtual

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.

该项目将利用功能性电气功能，使完全瘫痪的人恢复手臂和手的功能 刺激（FES）将使这些人能够以有效且有效的方式指挥这些动作 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 组件可实现功能齐全且可逆 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。 5名患有重度（C1-C4）脊髓损伤的人的瘫痪肌肉将被植入 使用 FES 电极来恢复手臂和手的多种运动，足以进行有意义的多关节， 功能活动。在同一个体中，96 通道皮质内阵列（“BrainGate2”）将被植入 初级运动皮层的手臂/手区域，产生的信号将用于命令 通过“思想”来控制参与者的手臂和手。该系统的主要组成部分是： 肌内注射 带经皮导线的电极 (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 具有实时操作系统（Matlab xPC Target）作为 FES 控制器的计算机。参加者将是 有强烈的动机去优化一个功能齐全的系统的性能，这让他们自己陷入瘫痪 武器，他们将有充足的机会练习和学习界面。我们将测试控制 已在类似应用中广泛使用的三种不同命令接口的性能：(1) 连续轨迹控制在以往的BMI研究中广泛使用，（2）基于运动目标的控制广泛使用 用于控制机械臂，以及（3）基于状态的“门控斜坡”控制，广泛用于控制人工 假肢。参与者将执行相同的一组标准动作以及功能性活动 与每个接口。我们将基于以下内容比较每种命令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，并将 使用这三个参数来表征神经信号属性（调谐和调制深度）的变化 接口。该项目将首次直接测试人体皮质内BMI控制的可行性 FES 上肢系统，因此我们的结果将指导未来完全植入的 BMI 系统的规格。我们的 团队在开发和测试上肢 FES 系统（包括患有以下疾病的人）方面拥有 30 多年的经验 手臂完全瘫痪。过去 7 年里，我们一直致力于开发人类皮质内 BMI， 获得监管部门的全面批准，并在克利夫兰建立了 BrainGate2 临床站点。这个项目是一个自然 通过将 FES 和 BMI 方法结合起来治疗 SCI 患者，扩展了我们过去的工作。技术风险 该项目的投资相对较低，但潜在的科学和康复回报非常高。