Deployment of a Mobile Broadband BCI

1皮质内神经接口，记录和分析记录的神经信号流 2从电极阵列植入大脑，可以实现快速、准确、直观的控制 3为因脊髓损伤而瘫痪的患者启用辅助技术，如 4以及中风和肌萎缩侧索硬化症等其他神经系统疾病。四肢瘫痪的个体 5使用想象中的BrainGate(IDE*)皮质内神经接口系统的试点临床试验 他们自己瘫痪的手和手臂的6个动作来指挥计算机的点击 7光标(屏幕上打字、聊天、网页浏览等通信应用程序)和控制 8种辅助设备，包括DEKA义肢/手，辅助机器人，甚至REACH和 9用自己瘫痪的肢体抓握，通过对瘫痪的人进行图案刺激而恢复活力 10块肌肉。这些BrainGate活动在研究参与者的家中进行，但需要一个 11记录电缆系在参与者和大型信号处理机架之间 12台计算机规定，IBCI只能在直接技术监督下使用 13个专门的研究周期。然而，随着最近推出的高带宽、微型 14个无线神经信号发射器(以消除系留电缆)和最先进的 15紧凑的信号处理设备，具有足够的计算资源来执行 16个BrainGate算法，这些组件可用于支持试验参与者和护理人员 17在家中使用和管理无线、移动皮质内脑机接口(IBCI) 18支持全天候和全家随时随地按需访问数字。 19本研究旨在评估在移动套餐中部署IBCI的可行性和实用性 20在家中独立使用，无需技术监督。除了评估新的 21移动平台，这将展示首次在家中使用皮质内BCI 22直接技术监督。将对最终用户和护理人员进行培训，以配置和操作 23 IBCI。随着IBCI安装在他们的轮椅上，以及一台安装在椅子上的消费平板电脑，完 24名四肢瘫痪的用户将能够使用他们自己想象的手臂和手的动作来 25个控制熟悉的平板电脑“应用程序”在家里的任何地方按需。将移动IBCI移动到 26床边将允许在床上使用片剂或整夜监测神经信号。 27在部署之前，目前的移动IBCI原型-最近由VA资助开发 28项研究-将配备最新的最先进的信号处理和神经 29种译码算法是在BrainGate试点临床试验中开发的。这将涉及到翻译 30将那些实时的软件算法转化为硬件描述语言来编程的超强 31低功耗片上系统器件。最近纳入的算法将使快速、 32无需专家干预即可自动校准BCI；在更长时间内保持校准 33个时间段，以减少对显式重新校准步骤的需要；并提高速度和 34从用户的神经信号得出的光标轨迹的准确性。三个用户中的每一个都将 35在连续5至10天的时间内对系统进行评估，并在 36连续3个月以上。自始至终，BCI系统的技术操作和 将对37个BrainGate算法进行监控和量化评估。此外，用户和 38名护理者将完成问卷调查，以衡量他们对该系统不断变化的满意度 39及其效用。对这些累积数据的分析将为未来的设备改进提供信息。 40*注意：调查设备。受联邦(美国)法律限制只能用于调查

1 Intracortical neural interfaces, which record and analyze streams of neural signals recorded 2 from arrays of electrodes implanted in the brain, can enable fast, accurate, intuitive control of 3 enabling assistive technologies for individuals with paralysis arising from spinal cord injury as 4 well as other neurological conditions including stroke and ALS. Individuals with tetraplegia in the 5 pilot clinical trial of the BrainGate (IDE*) intracortical neural interface system use imagined 6 movements of their own paralyzed hand and arm to command point-and-click with a computer 7 cursor (on-screen typing, communication apps such as chat, web browsing) and to control 8 assistive devices including the DEKA prosthetic arm/hand, assistive robots and even reach and 9 grasp with one’s own paralyzed limb reanimated through patterned stimulation of the paralyzed 10 muscles. These BrainGate activities take place in study participants’ homes, but the need for a 11 recording cable tethered between the participant and a large rack of signal processing 12 computers dictates that the iBCI can only be used under direct technical supervision during 13 dedicated research periods. However, with the recent availability of a high-bandwidth, miniature 14 wireless neural signal transmitter (to eliminate the tethering cable) and a state-of-the-art 15 compact signal processing device with sufficient computational resources to execute the 16 BrainGate algorithms, the components are available to enable trial participants and caregivers 17 to use and administer a wireless, mobile intracortical brain-computer interface (iBCI) at home to 18 enable on-demand digital access throughout day and night and throughout the home. 19 This study aims to evaluate the feasibility and utility of an iBCI deployed in a mobile package 20 for independent use at home without technical supervision. In addition to evaluating the new 21 mobile platform, this will demonstrate the first-ever in-home use of an intracortical BCI without 22 direct technical oversight. End users and caregivers will be trained to configure and operate the 23 iBCI. With the iBCI mounted to their wheelchair and a chair-mounted consumer tablet, end 24 users with tetraplegia will be able to use their own imagined arm and hand movements to 25 control familiar tablet “apps” on demand anywhere in the home. Moving the mobile iBCI to the 26 bedside will enable tablet use from bed or neural signal monitoring through the night. 27 Before deployment, the current prototype mobile iBCI - developed in recent VA funded 28 research - will be provisioned with the most recent state-of-the-art signal processing and neural 29 decoding algorithms developed in the BrainGate pilot clinical trial. This will involve translating 30 those real-time software algorithms into hardware description language to program the ultra- 31 low-power System-on-Chip device. Recent algorithms to be incorporated will enable rapid, 32 automatic calibration of the BCI without expert intervention; maintain calibration over longer 33 periods of time to reduce the need for explicit recalibration steps; and improve the speed and 34 accuracy of cursor trajectories derived from the user’s neural signals. Each of three users will 35 evaluate the system over a continuous 5 to 10 day period, and repeat the home assessment in 36 at least 3 consecutive months. Throughout, the technical operation of the BCI system and the 37 BrainGate algorithms will be monitored and evaluated quantitatively. In addition, user and 38 caregivers will complete questionnaires measuring their evolving satisfaction with the system 39 and its utility. Analyses of these cumulative data will inform future device improvements. 40 *CAUTION:Investigational Device.Limited by Federal (United States) Law to Investigational Use