CPS: TTP Option: Frontier: Collaborative Research: A Bi-Directional Brain-Computer Interface for Restoration of Walking and Lower Extremity Sensation after Spinal Cord Injury

行走功能丧失和腿部感觉丧失是脊髓损伤(SCI)的毁灭性后果。这些赤字对受影响的人的独立性和生活质量产生了深远的负面影响。此外，脊髓损伤后对轮椅的依赖增加了医疗并发症的风险。与脊髓损伤相关的医疗费用约为500亿美元/年，这是一个重大的公共卫生问题。目前，还没有能够恢复脊髓损伤后行走和腿部感觉的生物医学解决方案。这些重要问题迫切需要具有临床实用性和社会可接受性的解决方案。使用计算机物理系统(CPS)绕过受损的脊髓可能是恢复因脊髓损伤而导致的腿部瘫痪患者行走和腿部感觉的一种新方法。拟议的多学科努力将激励来自传统贫困和代表性不足群体的学生在STEM领域继续接受大学教育，展示工程和科学如何能够改变残疾人的福祉。此外，它还将使残疾人及其家庭成员、朋友和照顾者获得教育机会，以提高他们的科学和技术素养。通过利用奥兰治县和洛杉矶县不同的种族构成、三个研究地点的地理位置接近、使外联活动易于融合以及该项目具有高度的社会意义和知名度，将实现对这些社区的外联。脊髓损伤(SCI)后，常见的是步态功能受损或完全丧失以及下肢感觉。一种新的计算机物理系统CPS可以被实现为一个永久可植入的双向(BD)脑机接口(BCI)，它将行走意图从大脑信号转换为腿部假肢的命令，并将假肢传感器信号转换为对大脑的电刺激，以实现人工腿的感觉。这种闭环手术将接近于恢复脊髓损伤后的肢体行走和腿部感觉。在将这种可植入的CPS应用于人体之前，必须确定其可行性和安全性。该Frontier项目的主要目标是设计、开发和测试一种用于行走和腿部感觉的基于完全植入式皮层脑电(ECoG)的BD-BCI的可穿戴模拟物。BD-BCI CPS将设计为超低功耗模块化系统，采用革命性的干扰缓解技术，能够同时进行电刺激和录音。第一个模块将由一个定制的大脑信号采集系统组成，该系统利用ECoG信号属性显著降低功耗。第二个模块将由低功率处理单元、大脑刺激器和无线通信收发器组成。该模块将在内部执行优化的BCI算法，并将命令无线传输到机器人步态外骨骼以供行走。将进行全面的台式和床边测试，以评估系统的正常功能。最后，因脊髓损伤而截瘫的受试者将被招募接受为期30天的ECoG植入，以测试BD-BCI恢复脑控行走和腿部感觉的能力。过渡到实践(TTP)的目标是：(1)开发BD-BCI的完全可植入版本，(2)执行一系列工业标准的医疗设备台式测试，以及(3)测试植入物的安全性。

Loss of walking function and leg sensation are devastating consequences of spinal cord injury (SCI). These deficits have a profoundly negative impact on independence and quality of life of those affected. Moreover, wheelchair reliance after SCI increases the risk of medical complications. The healthcare costs associated with SCI are ~$50 billion/year, presenting a significant public health concern. Currently, there are no biomedical solutions capable of restoring walking and leg sensation after SCI. Clinically practical and socially acceptable solutions to these important problems are desperately needed. Employing a cyber-physical system (CPS) to bypass the damaged spinal cord may be a novel way to restore walking and leg sensation to those with leg paralysis due to SCI. The proposed multi-disciplinary effort will inspire students from traditionally underprivileged and underrepresented groups to pursue college education in STEM fields by demonstrating how engineering and science can make a difference in the well-being of those with disabilities. In addition, it will engage individuals with disabilities, their family members, friends, and caregivers, in educational opportunities in order to increase their scientific and technical literacy. The outreach to these communities will be accomplished by leveraging diverse ethnic makeup of Orange and Los Angeles Counties, geographic proximity of the three study sites, which makes outreach activities amenable to integration, and the high societal significance and visibility of the project. Impairment or complete loss of gait function and lower extremity sensation are common after spinal cord injury (SCI). A new cyberphysical system, CPS, can be realized as a permanently implantable bi-directional (BD) brain-computer interface (BCI), which translates walking intentions from brain signals into commands for a leg prosthesis, and converts prosthesis sensor signals into electrical stimulation of the brain for artificial leg sensation. This closed-loop operation would come close to restoring able-body-like walking and leg sensation after SCI. Before such an implantable CPS is deployed in humans, its feasibility and safety must be established. The main objective of this Frontier project is to design, develop, and test a wearable analogue of a fully implantable electrocorticogram (ECoG)-based BD-BCI for walking and leg sensation. The BD-BCI CPS will be designed as an ultra-low power modular system with revolutionary techniques for interference mitigation to enable simultaneous electrical stimulation and recording. The first module will consist of a custom brain signal acquisition system that exploits ECoG signal attributes to significantly reduce power consumption. The second module will consist of a low-power processing unit, brain stimulator, and wireless communication transceiver. This module will internally execute optimized BCI algorithms and wirelessly transmit commands to a robotic gait exoskeleton for walking. Comprehensive benchtop and bedside tests will be conducted to assess proper system function. Finally, subjects with paraplegia due to SCI will be recruited to undergo a 30-day ECoG implantation to test the BD-BCI's ability to restore brain-controlled walking and leg sensation. The goals of transition to practice (TTP) are to: (1) develop a fully implantable version of the BD-BCI, (2) perform a series of industrial-standard medical device benchtop tests, and (3) test the implants safety.