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.

该项目将使用功能电气恢复完全麻痹的个体的手臂和手部功能 刺激（FES），将使这些人有效地命令这些运动，并且 使用心脏内脑机界面（BMI）的直观方式。我们将使用经皮接口 FES和BMI组件以实现功能齐全但也可逆的BMI命令FES 系统。这是永久植入BMI控制的最终实现的下一步 FES系统。将植入5个高水平（C1-C4）的5个个体的瘫痪肌肉。 用FES电极恢复手臂的多个运动，足以有意义的多关节， 功能活动。在同一个人中，将植入一个96通道内阵列（“ Braingate2”） 主电机皮层的手臂/手部位，由此产生的信号将用于指挥动作 参与者的手臂和手通过“思想”。所提出系统的主要组成部分是：肌内 具有经皮铅的电极（Ardiem Medical），外部刺激器（FES中心），Braingate22 皮质内阵列和相关的外部硬件（贝莱德微型系统的神经托管）和标准 具有实时操作系统（MATLAB XPC目标）的计算机作为FES控制器。参与者会 强烈的动力以优化功能齐全的系统的性能，以使自己的瘫痪 武器，他们将有足够的机会练习和学习界面。我们将测试控件 在类似应用中广泛使用的三个不同命令接口的性能：（1） 在先前的BMI研究中广泛使用的连续轨迹控制，（2）基于移动目标的控制广泛使用 用于控制机器人臂，以及（3）基于状态的“门控坡道”控制，用于控制人工 假肢。参与者将执行相同的标准运动以及功能活动 每个接口。我们将根据基于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，一致性随时间，功能性能，功能性能， 易用性）。我们还将评估M1产生连续，目标和状态命令的能力，并将 在使用这三个时，表征神经信号特性的变化（调整和调制深度） 接口。该项目将首次直接测试人体内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系统方面拥有30多年的经验，包括 完全手臂瘫痪。在过去的7年中，我们一直在努力开发人体内BMI 全面的监管批准，并在克利夫兰建立了一个临床Braingate2站点。这个项目是自然的 通过将FES和BMI方法结合在一起，扩大了过去的工作。技术风险 该项目的相对较低，但是潜在的科学和康复回报率很高。