BrainGate Pilot Clinical Trials: Progress toward the Restoration of Communication and Mobility for People with Paralysis

• ¹ Massachusetts General Hospital, Harvard Medical School, United States

Just over a decade ago, neural interfaces research entered a new era with the beginning of the BrainGate (www.braingate2.org) pilot clinical trials (IDE). For the first time, it became possible to record chronically – for years at a time – single neuron, multi-unit, and local field potential activity from the human brain. The reasons for making this clinical translation were clear, and remain true today: For people with cervical spinal cord injury, pontine stroke, neuromuscular disease including amyotrophic lateral sclerosis, upper extremity limb loss, and other neurologic illnesses and injuries, currently available assistive and rehabilitation technologies are inadequate. The BrainGate clinical research model, now adopted by several impressive scientific teams across the US, is translating preclinical research generally performed with healthy, neurologically intact non-human primates, into the direct neural control of virtual and physical devices by people with tetraplegia. A variety of methods for decoding brain signals are now being tested with the hope of not only restoring communication, but also providing an intuitive control signal for the reanimation of paralyzed limbs. Ongoing progress in neural decoding, systems engineering, and wireless technologies highlight both the opportunities and challenges of future, high-bandwidth, fully implanted neural interfaces. (1) Hochberg L.R., et al. Neuronal ensemble control of prosthetic devices by a human with tetraplegia. Nature. 2006; 442(7099):164-71. (2) Truccolo W., et al. Primary motor cortex tuning to intended movement kinematics in humans with tetraplegia. Journal of Neuroscience, 2008; 28(5);1163-1178. (3) Simeral, J.D. et al. Neural control of cursor trajectory and click by a human with tetraplegia 1000 days after implant of an intracortical microelectrode array. J. Neural Engin. 2011; 8(2) 02027. (4) Truccolo, W. et al. Single neuron dynamics in human focal epilepsy. Nature Neuroscience 2011. (5) Chadwick, E.K. et al. Continuous neuronal ensemble control of simulated arm reaching by a human with tetraplegia. J. Neural Engin. 2011 8(3): 034003. (6) Hochberg, L.R., Bacher, D, Jarosiewicz, B, Masse, N.Y., Simeral, J.D., Vogel, J, Haddadin, S., Liu, J., van derSmagt, P., Donoghue, J.P. Reach and grasp by people with tetraplegia using a neurally controlled robotic arm. Nature. 2012 May 17; 485 (7398): 372-5. (7) Jarosiewicz B, Masse NY, Bacher D, Cash SS, Eskandar E, Friehs G, Donoghue JP, Hochberg LR. Advantages of closed-loop calibration in intracortical brain-computer interfaces for people with tetraplegia. J Neural Eng. 2013 Aug;10(4):046012. (8) Collinger JL, Wodlinger B, Downey JE, Wang W, Tyler-Kabara EC, Weber DJ, McMorland AJ, Velliste M, Boninger ML, Schwartz AB. High-performance neuroprosthetic control by an individual with tetraplegia. Lancet. 2013 Feb 16;381(9866):557-64. (9) Bacher D, Jarosiewicz B, Masse NY, Stavisky SD, Simeral JD, Newell K, Oakley EM, Cash SS, Friehs G, Hochberg LR. Neural Point-and-Click Communication by a Person With Incomplete Locked-In Syndrome. Neurorehabil Neural Repair. 2014 Nov 10 (epub ahead of print). (10 ) Yin M, Borton DA, Komar J, Agha N, Lu Y, Li H, Laurens J, Lang Y, Li Q, Bull C, Larson L, Rosler D, Bezard E, Courtine G, Nurmikko AV. Wireless neurosensor for full-spectrum electrophysiology recordings during free behavior. Neuron. 2014 Dec 17;84(6):1170-82.