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.

该项目的目标是开发一种无线的、完全可植入的双向皮质神经假体系统(W-ICONS)，通过与初级运动和感觉皮质的完整上肢区域的接口来恢复感觉运动功能。能够与大脑进行直接通信的技术越来越显示出恢复高度脊髓损伤患者的独立性的希望。尽管取得了这些进展，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、广泛的布线以及用于记录和刺激神经活动的笨重设备。此外，这些设备通常都专门配备了神经记录功能。W-icons设备将是首个用于四肢瘫痪患者的无线双向神经记录和刺激皮质植入物，为实验室环境以外的使用创造了一个真正的便携设备。这项拟议的转译研究得益于十多年来对微电极阵列的临床研究，证明了在恢复丧失的感觉运动功能方面的安全性和有效性。Brain Gate和革命性假肢的临床试验表明，可以实现并保持对假肢和通信设备的功能相关控制多年。最近来自多个小组(包括我们自己)的研究表明，皮层内微刺激(ICMS)可以提供稳定的、局部的感觉知觉，能够提高伸展和抓取任务的任务绩效。关键的是，我们的团队已经领导并获得了FDA和机构监管机构的批准，进行了四次首次人类演示。在这里，我们将扩展我们团队最先进的完全植入式无线记录系统，增加刺激功能。W-icons系统的台式验证(Aim 1)之后将在动物模型中对该设备进行临床前测试，这将支持FDA提交的IDE文件(Aim 2)，以在JHU进行W-icons与患有高位脊髓损伤(四肢瘫痪)的患者的早期可行性研究(Aim 3)。JHU的这项临床研究的目的是在为期一年的研究(至少)中，在两名参与者身上验证W-ICON系统的慢性安全性和有效性。在研究期间，如果由于安全原因没有解释该设备，则将证明其安全性。有效性的展示将需要在挑选和放置任务(例如，行动研究手臂测试)中控制传感机械臂，并报告手部区域对ICMS的感知。成功的演示将支持一项研究方案修正案，以超过一年的植入时间，并将该设备的使用过渡到患者家中。