High-Bandwidth Wireless Interfaces for Continuous Human Intracortical Recording

 描述（由申请人提供）：神经系统疾病，包括颈脊髓损伤、脑干卒中和肌萎缩侧索硬化症，可导致四肢严重瘫痪。在美国，超过10万人因这些疾病和其他疾病而四肢瘫痪，最极端的形式可能导致所有自愿运动的丧失和言语的丧失（闭锁综合征）。在过去的10年里，基于皮层的脑机接口已经开发出来，希望恢复自愿，直观，灵活，全天候控制外部设备，如计算机光标，或内部神经肌肉刺激器能够恢复肢体运动。在人类中，将这些强大的、高带宽的、颅内记录的神经信号传送到外部神经解码器需要经皮组件，这些组件将用户束缚在附近的技术上，并且需要定期的护理人员协助以降低感染的风险。我们已经创建并执行了一个完全植入的高带宽神经记录系统的初始非临床测试，该系统可以将100个通道的神经元集合数据传输到1米远的接收器。这个紧密合作的多机构项目汇集了神经病学，神经外科，神经科学，神经工程和医疗器械临床试验的领导者，以（1）完成这种下一代技术的制造和监管评估，以及（2）进行严格的早期可行性研究，其中六名四肢瘫痪的参与者将在家中测试研究性BrainGate 3神经接口系统，至少一年这项研究将提供一种新型神经技术平台的早期临床经验，并将为下一代闭环神经记录和刺激设备的开发提供信息，以帮助管理神经系统和神经精神疾病的症状。

 DESCRIPTION (provided by applicant): Neurologic disorders including cervical spinal cord injury, brainstem stroke, and amyotrophic lateral sclerosis can lead to severe paralysis of all fou limbs. More than 100,000 people in the US have tetraplegia from these and other disorders, which in their most extreme forms can lead to loss of all voluntary movement and the loss of speech (locked-in syndrome). Over the past 10 years, intracortically based brain-computer interfaces have been developed with the hope of restoring voluntary, intuitive, flexible, and around-the-clock control of external devices such as a computer cursor, or internal neuromuscular stimulators capable of reanimating limb movement. In humans, conveying these powerful, high-bandwidth, intracranially recorded neural signals to external neural decoders has required percutaneous components that tether the user to nearby technologies and require regular caregiver assistance to reduce the risk of infection. We have created and performed initial nonclinical testing of a fully implanted, high bandwidth neural recording system that can transmit 100 channels of neuronal ensemble data to receivers up to 1 meter away. This tightly collaborative, multi-institutional project brings together leaders in neurology, neurosurgery, neuroscience, neuroengineering, and medical device clinical trials to (1) complete the manufacture and regulatory assessment of this next- generation technology, and (2) perform a rigorous Early Feasibility Study in which six participants with tetraplegia will test the investigational BrainGate3 Neural Interface System, at home, for at least one year. This study will provide early clinical experience with a novel neurotechnology platform, and will inform the development of next-generation closed-loop neural recording and stimulating devices to help manage the symptoms of neurologic and neuropsychiatric disease.