Wireless Implantable COrtical Neuroprosthetic System (W-ICONS)

无线植入式皮质神经假体系统 (W-ICONS)

• 批准号: 10576751
• 负责人: Francesco V Tenore
• 金额: $ 126.16万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10576751
• 关键词: Action Research; Activities of Daily Living; Affect; Amendment; Animal Model; Area; Artificial Arm; Brain; Chronic; Clinical Research; Clinical Trials; Cochlear Implants; Communication; Data; Device Safety; Devices; Environment; Feasibility Studies; Feedback; Goals; Hand; Histologic; Home; Home environment; Human; Implant; Individual; Institution; Interview; Laboratories; Limb structure; Microelectrodes; Motor; Motor Cortex; Neurodegenerative Disorders; Neuromuscular Diseases; Participant; Patients; Perception; Performance; Periodicals; Persons; Preclinical Testing; Prosthesis; Protocols documentation; Quadriplegia; Reaction; Reporting; Research Personnel; Robotics; Safety; Sensorimotor functions; Sensory; Somatosensory Cortex; Spinal cord injury; Standardization; System; Tactile; Task Performances; Technology; Testing; Time; Tissue Viability; Universities; Upper Extremity; Validation; arm; brain machine interface; communication device; first-in-human; grasp; implantation; improved; integrated circuit; microstimulation; motor control; motor impairment; neural; neural stimulation; neuroprosthesis; neuroregulation; novel; portability; preclinical efficacy; preclinical safety; research study; restoration; safety study; sensor; sensory cortex; sensory feedback; sheep model; subcutaneous; telemetering; translational study; wireless; wireless implant

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.

该项目的目的是开发无线，完全植入的，双向皮质神经假体系统（W-ICON），以通过具有完整的主电动机和感觉皮质的完整上肢区域来恢复感觉运动功能。能够与大脑进行直接沟通的技术越来越有望恢复受高脊髓损伤影响的人的独立性。尽管有这些进展，但神经界面系统仍主要局限于实验室环境，需要一组研究人员处理繁琐的经界接口，广泛的接线和笨重的设备，以记录和刺激神经元活动。此外，这些设备通常等效于中性记录功能。 W-ICONS设备将是第一个无线双向的（对神经元记录和刺激）的双向植入物，是对四边形个体的皮质植入物，创建了一个真正的便携式设备，用于在实验室环境之外使用。这项拟议的翻译研究受益于十多年的微电极阵列临床研究，这表明了恢复失去的感觉运动功能的安全性和效率。大脑门和革命性的假肢临床试验表明，可以实现和维护对假肢和通信设备的功能相关控制多年。来自多个小组（包括我们自己的）的最新研究表明，皮质内微刺激（ICMS）可以提供稳定的，局部的感觉知觉，能够改善触及和抓紧任务的任务绩效。至关重要的是，我们的团队领导并获得了四次人类示威活动的FDA和机构监管机构批准。在这里，我们将通过添加模拟功能来扩展团队最先进的完全可植入的无线录音系统。 JHU临床研究目的的台式验证是在一项为期1年的研究（最低限度）中验证两个参与者中W-ICON系统的慢性安全性和有效性。如果由于在研究期间的安全原因而无法探索设备，将证明安全性。效率的证明将需要在接地任务（例如，动作研究组测试）中控制传感器机器人臂，并报告了手动区域中ICM的感知。成功的演示将支持一项研究方案修正案，以超越植入一年，并向患者的房屋过渡。