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

行走功能和腿部感觉的丧失是脊髓损伤（SCI）的毁灭性后果。这些缺陷对受影响者的独立性和生活质量产生了深刻的负面影响。此外，SCI后对轮椅的依赖增加了医疗并发症的风险。与SCI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SCI后行走和腿部感觉的生物医学解决方案。迫切需要临床上切实可行和社会上可接受的解决这些重要问题的办法。采用网络物理系统（CPS）绕过受损的脊髓可能是一种新的方法，以恢复行走和腿部感觉那些腿部瘫痪由于SCI。 拟议的多学科努力将通过展示工程和科学如何在残疾人的福祉方面发挥作用，激励传统上弱势和代表性不足的群体的学生在STEM领域接受大学教育。此外，它还将使残疾人及其家人、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。将通过利用橙子县和洛杉矶县的不同种族构成、三个研究中心的地理邻近性（这使得外展活动易于整合）以及该项目的高度社会意义和知名度来实现对这些社区的外展。脊髓损伤（SCI）后步态功能和下肢感觉受损或完全丧失是常见的。一种新的网络物理系统CPS可以实现为永久植入式双向（BD）脑机接口（BCI），它将大脑信号中的行走意图转换为假肢的命令，并将假肢传感器信号转换为大脑的电刺激，以实现人工腿的感觉。这种闭环手术将接近于恢复SCI后的健全身体般的行走和腿部感觉。在这种植入式CPS部署在人体之前，必须确定其可行性和安全性。这个前沿项目的主要目标是设计，开发和测试一个完全植入式的基于皮层脑电图（ECoG）的BD-BCI的可穿戴模拟物，用于行走和腿部感觉。BD-BCI CPS将被设计为超低功耗模块化系统，具有革命性的干扰缓解技术，可实现同步电刺激和记录。第一个模块将包括一个定制的大脑信号采集系统，该系统利用ECoG信号属性来显著降低功耗。第二个模块将由低功率处理单元、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进行行走。将进行全面的台式和床旁测试，以评估系统功能是否正常。最后，将招募因SCI导致截瘫的受试者进行为期30天的ECoG植入，以测试BD-BCI恢复大脑控制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的完全植入式版本，（2）执行一系列工业标准医疗器械台架测试，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.