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质的完整上肢区域的接口恢复感觉运动功能。能够与大脑直接通信的技术越来越有希望恢复受高位脊髓损伤影响的人的独立性。尽管有这些进步，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，这些装置通常专门配备有神经记录能力。W-ICONS设备将是第一个无线的，双向的，结合神经记录和刺激皮层植入四肢瘫痪的个人，创造一个真正的便携式设备，用于实验室环境之外。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，证明了恢复丧失的感觉运动功能的安全性和有效性。Brain Gate和Revolutionizing Prosthetics临床试验表明，对假肢和通信设备的功能相关控制可以实现并保持多年。最近的研究表明，皮质内微刺激（ICMS）可以提供稳定的，局部的感官知觉，能够提高任务性能的达到和把握任务。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。对W-ICONS系统进行台架验证（目标1）后，将在动物模型中对器械进行临床前试验，这将支持FDA IDE提交（目标2），以便在JHU对受高位脊髓损伤（四肢瘫痪）影响的个体进行W-ICONS早期可行性研究（目标3）。JHU临床研究的目的是在为期1年的研究（至少）中，在2名受试者中确认W-ICON系统的长期安全性和有效性。如果在研究期间由于安全性原因未停用器械，则将证明其安全性。功效的证明将需要在拾取和放置任务中控制传感器化的机器人臂（例如，行动研究手臂测试），并报告了手部区域的ICMS感知。成功的演示将支持研究方案修订，以超过一年的植入，并将器械的使用转移到患者家中。