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、完全植入式、双向皮质神经假体系统（W-ICONS），通过与初级运动和感觉皮层完整上肢区域的接口恢复感觉运动功能，从而实现直接通信。尽管取得了这些进步，大脑越来越有希望恢复受高位脊髓损伤影响的人的独立性，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、广泛的接线和连接。此外，这些设备通常专门配备了神经记录功能，这将是第一个无线、双向（结合了神经记录和刺激）四肢瘫痪患者的皮层植入物。这项拟议的转化研究受益于十多年的微电极阵列临床研究，证明了大脑门和革命性假肢临床试验在恢复失去的感觉运动功能方面的安全性和有效性。许多团体（包括我们自己的团体）最近的研究表明，皮质内微刺激（ICMS）可以提供稳定的、局部的感觉知觉，从而能够改善任务。至关重要的是，我们的团队已领导并获得了 FDA 和机构监管机构的四次首次人体演示的批准。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。系统增加了刺激功能。W-ICONS 系统的台式验证（目标 1），随后将在动物模型中对该设备进行临床前测试，将支持 FDA IDE 提交（目标 2）以进行早期可行性研究。 JHU 的 W-ICONS 研究（目标 3）针对高位脊髓损伤（四肢瘫痪）患者。JHU 临床研究的目的是验证 W-ICON 系统在两名参与者中的长期安全性和有效性。在为期 1 年的研究中（至少），如果在研究期间由于安全原因未移植该设备，则需要在拾取和放置任务（例如动作）中控制传感机械臂来证明其安全性。研究手臂测试）和报告的手部区域 ICMS 感知将支持研究方案修订，以超过一年的植入时间并将该设备的使用转移到患者家中。