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
VA research has been advancing a high-performance brain-computer interface (BCI), BrainGate, to improve independence for Veterans and others living with tetraplegia and to restore communication for individuals whose paralysis results in the inability to speak (due, for example, to amyotrophic lateral sclerosis, ALS). In supervised research sessions, BrainGate has enabled individuals with severe paralysis to communicate and use computers by imagining their own hand movements to control point-and-click actions for on-screen typing, browsing the web and other familiar enabling activities. In recent work, the computational power of the BrainGate BCI was condensed to a compact, state-of-the-art, battery-powered device. In this project, individuals with tetraplegia will use the new BCI mounted on their wheelchair to evaluate its utility and ease of use at home over days of unsupervised, spontaneous, self-paced daily life.
