Wireless Implantable COrtical Neuroprosthetic System (W-ICONS)

该项目的目标是开发一种无线，完全植入式，双向皮质神经修复系统（W-ICONS），通过与完整的上肢初级运动和感觉皮层区域的界面恢复感觉运动功能。能够与大脑直接交流的技术越来越多地显示出恢复高度脊髓损伤患者独立性的希望。尽管取得了这些进步，但神经接口系统仍然主要局限于实验室环境，需要一组研究人员处理繁琐的经皮接口、广泛的布线和笨重的设备来记录和刺激神经活动。此外，这些设备通常只配备了神经记录功能。W-ICONS设备将是第一个无线、双向结合神经记录和刺激的皮质植入物，用于四肢瘫痪患者，创造了一个真正的便携式设备，可在实验室环境外使用。这项建议的转化研究得益于十多年来微电极阵列的临床研究，证明了恢复失去的感觉运动功能的安全性和有效性。脑门和革命性假肢临床试验已经证明，对假肢臂和通信设备的功能相关控制可以实现并维持多年。最近一些研究小组（包括我们自己的小组）的研究表明，皮质内微刺激（ICMS）可以提供稳定的、局部的感觉知觉，能够提高在伸手抓握任务中的任务表现。至关重要的是，我们的团队已经领导并获得了FDA和机构监管部门的批准，进行了四次首次人体试验。在这里，我们将扩展我们团队最先进的全植入式无线录音系统并增加刺激功能。W-ICONS系统的台式验证（目标1），随后是该设备在动物模型中的临床前测试，将支持FDA IDE提交（目标2），以便在JHU对高脊髓损伤（四肢瘫痪）患者进行W-ICONS的早期可行性研究（目标3）。JHU临床研究的目的是在至少1年的研究中验证W-ICON系统在两名参与者中的慢性安全性和有效性。如果在研究期间由于安全原因未将设备取出，将证明其安全性。效能演示将需要在拾取和放置任务中控制感应机械臂（例如，行动研究手臂测试），并报告手部区域的ICMS感知。成功的演示将支持一项研究方案修正案，使植入时间超过一年，并将该设备过渡到患者家中使用。

The goal of this project is to develop a Wireless, fully Implantable, bidirectional Cortical Neuroprosthetic System (W-ICONS) for restoring sensorimotor function through an interface with intact upper limb areas of primary motor and sensory cortex. Technologies that enable direct communication to and from the brain have increasingly shown promise for restoring independence to people affected by high spinal cord injuries. Despite these advances, neural interface systems are still mostly confined to laboratory settings, requiring a team of researchers to handle cumbersome transcutaneous interfaces, extensive wiring, and bulky devices for recording and stimulating neural activity. Further, these devices have typically been equipped exclusively with neural recording capabilities. The W-ICONS device would be the first wireless, bidirectional—incorporating neural recording and stimulation—cortical implant for tetraplegic individuals, creating a truly portable device for use outside the lab environment. This proposed translational study benefits from over a decade of clinical studies with microelectrode arrays, demonstrating safety and efficacy in restoring lost sensorimotor functions. The Brain Gate and Revolutionizing Prosthetics clinical trials have demonstrated that functionally relevant control over prosthetic arms and communication devices can be achieved and maintained for years. More recent studies from a number of groups (including our own) have shown that intracortical microstimulation (ICMS) can provide stable, localized sensory percepts capable of improving task performance on reach-and-grasp tasks. Critically, our team has led and received FDA and institutional regulatory approvals for four first-in-human demonstrations. Here, we will be extending our team’s state-of-the-art fully implantable wireless recording system with the addition of stimulation capabilities. Benchtop verification of the W-ICONS system (Aim 1), will be followed by preclinical testing of the device in an animal model, will support an FDA IDE submission (Aim 2) to conduct an early feasibility study (Aim 3) at JHU of the W-ICONS with individuals affected by high spinal cord injury (tetraplegia). The aim of the clinical study at JHU is to validate chronic safety and efficacy of the W-ICON system in two participants in a 1-year study (minimum). Safety will be demonstrated if the device is not explanted due to safety reasons during the study period. Demonstration of efficacy will require control of sensorized robotic arms in pick- and-place tasks (e.g., Action Research Arm Test) and reported perception of ICMS in the hand area. Successful demonstrations will support a study protocol amendment to go beyond one year of implantation and to transition use of the device to patients’ homes.