June 2022 issue
June 30, 2022 | Several neurotech vendors and research teams pursuing advances in neuroprosthetics have reported significant developments in recent weeks. The steady progress offers hope to individuals with severe paralysis and other disabilities.
Synchron, makers of a novel endovascular BCI, announced in May that they received an IDE from the FDA for the first-ever permanently implanted BCI in a human clinical trial. Until now, implantations had not been approved for permanent use. The study will be performed at Mount Sinai Hospital in New York and marks the first U.S. implantation by the company. It is expected that the BCI will enable the user to regain the ability to control digital devices for hands-free use such as texting, emailing, e-commerce use, and communications. Synchron’s 8-mm nitinol mesh is implanted in a standard cath lab accessing the motor cortex through the superior sagittal sinus and is considered to be minimally invasive.
Just down the eastern seaboard, Johns Hopkins University and the Applied Physics Lab have imbued a partially paralyzed man with the ability to have his cake and eat it, too. The test subject, a man with partial arm paralysis, used his BCI to control two modular prosthetic arms by making small fist gestures. The robotic arms were used to hold a knife or fork, perform the manipulations required to cut the pastry, and to reposition the utensils and deliver the food to the patient’s mouth. While Cathy Hutchinson, the Braingate patient who demonstrated an eating task (with her beloved chocolate) without assistance was the first to demonstrate self-feeding in 2012, this represents the first use of bilateral coordination required to achieve the goal. The experiments also featured the ability to exercise preference for the size of the bite to be cut. While not always accurate, the selectivity is something that is typically taken for granted in our everyday lives.
Another “first” comes from the University of Pittsburgh’s Rehab Neural Engineering Lab. The lab, led by an impressive array of faculty, announced a new partnership with Blackrock Neurotech to allow study patients to use their implanted BCI systems at home. Except for limited deployment of take-home systems by Pitt, experimental systems have been confined to an intricate and large space in a lab environment. Under the agreement, the teams will scale future technologies to a much smaller footprint, which will help to increase the number of trial participants by virtue of mitigating the time, travel, and means required to contribute to the research process. As it stands today, life as a BCI patient participant requires a geographic proximity to study sites and significant time and financial freedom that is not widely available. As a result, fewer potential participants are able to join as study participants. Not only will the at-home format be accessible to more study participants, it will also allow researchers to expand the development and understanding of the processes and needs of people living with paralysis in their everyday lives.
Blackrock enjoys a solo accolade in the BCI development headlines as well. Earlier this month, the company announced that its BCI system has achieved 30,000 days of patient implantations—that’s more than 82 years of implants. The milestone announcement came shortly after Synchron’s statement of the first FDA clearance for the implantation of a permanent BCI. While the timing could be construed as reactionary, the truth is it is anything but. Blackrock has earned bragging rights in the BCI community since 2004 as a University of Utah research effort and as a commercial concern dating back to 2008. Of the 36 known people to have received implanted BCIs, Blackrock technology has been used in 32 patients. They were also the first BCI implanted in a human in 2004 and boast the longest chronic implantation to date—seven years and counting.
And finally, we wrap up with BCI newcomer Neuvotion. Neuvotion is helmed by BCI veteran Chad Bouton. Bouton was a lead investigator on Battelle’s NeuroLife project in which Ian Burkhart was implanted with a Blackrock device for the purposes of restoring limb movement after a spinal cord injury resulted in his C5 tetraplegia. The successful study lasted longer than seven years and saw much acclaim and national press coverage with a special focus on Ian’s ability to play Guitar Hero.
Bouton, now with the Feinstein Institute for Medical Research, launched Neuvotion in 2019 and has continued his work to help patients with paralysis to restore function and sensation. In a recent Wall Street Journal report, Sharon Laudisi, a patient with peripheral nerve damage, demonstrated that she regained movement and sensation in her left hand by using the noninvasive Neuvotion system. Laudisi recounted the frustration and embarrassment of her physical limitations but triumphs in the restorative effects she has seen after using the system. She attended more than 30 clinic sessions over the course of the year and has seen positive effects even while not using the system.
Bouton and his team have begun recruiting patients for the trial of an implanted system called NEURO TOUCH. In the trial, five Blackrock Neurotech electrodes will be placed in the motor and sensory cortices. Using AI to help process the signals, the system will interpret the brain signals and convert them into movement and sensation.
