Results of a clinical trial that assessed the safety of Synchron’s endovascular brain-computer interface in people with severe paralysis are being presented today at the Congress of Neurological Surgeons (CNS) by UB neurosurgeon Elad I. Levy.

For this abstract, Levy, a principal investigator, SUNY Distinguished Professor and L. Nelson Hopkins Endowed Chair of the Department of Neurosurgery in the Jacobs School of Medicine and Biomedical Sciences, is being awarded the Duke Samson Award, which the CNS gives to recognize the best clinical paper addressing a topic of cerebrovascular surgery.

Now that the initial follow-up of the feasibility study has been completed, patients will begin to be enrolled next year at additional sites in the U.S., one of which will be the Gates Vascular Institute (GVI) in Buffalo.

The COMMAND trial was conducted under the first investigational device exemption awarded by the Food and Drug Administration to a company assessing a permanently implanted brain-computer interface. The early feasibility study assessed safety while evaluating quantified efficacy measures of Synchron’s brain-computer interface device, which allows people with limited to no mobility to operate technology such as mobile devices and computers using their thoughts. The Synchron technology uses digital motor output, or DMO, to use peripheral assist devices to restore lost function. 

Through a minimally invasive endovascular procedure, the device is implanted in the blood vessel on the surface of the motor cortex of the brain via the jugular vein. Once implanted, it is designed to detect and wirelessly transmit motor intent out of the brain, intended to restore the capability for severely paralyzed people to have hands-free control over personal devices.

In the study, two patients were enrolled in Buffalo at the Gates Vascular Institute, two were enrolled at the University of Pittsburgh and two at Mount Sinai Health System.

Levy, who is also co-director of the Gates Stroke Center and Cerebrovascular Surgery at Kaleida Health’s Buffalo General Medical Center/Gates Vascular Institute and president of UB Neurosurgery (UBNS), explains the technology is designed to give functional independence back to patients who have become paralyzed.

“It takes a person who has to have everything done by a caretaker and it gives them back some independence and functionality through this brain-computer interface,” he says.

“Our group at UB and the GVI has been in the forefront of learning how to navigate complex devices in the venous system of the brain,” says Levy, “so it was a very natural choice for Synchron to come to Buffalo and have us do these initial cases. All of the research that we’ve done pioneering in strokes and, more specifically, in venous anatomy at the Jacobs School, as well as the clinical experience we have at Gates, was the reason we were selected to be one of the first places where this kind of procedure would be done.”

Allison Brashear, vice president for health sciences at UB and dean of the Jacobs School, agrees. “That our UB and Gates Vascular Institute neurosurgeons were selected to do this points to the fact that for the last 20 years, they have been at the forefront of neuroendovascular surgery, delivering paradigm-changing care to patients — not only in this region but globally,” Brashear says. “This continued pursuit of advanced technologies highlights our commitment to innovation and excellence in patient care.”

The strong partnership between the Department of Neurosurgery, the GVI and the Jacobs Institute allowed the Buffalo group to optimize the procedures before touching the patient. The Jacobs Institute is a vascular and neurologic medical device innovation center on the Buffalo Niagara Medical Campus.

Through this partnership, the bioengineers at the Jacobs Institute created engineered precision 3D printed models to scale of a patient’s anatomy and vascular structures.

“This allows us to continue to optimize and practice our procedures,” says Levy, “becoming very familiar with the patient’s brain anatomy so that when we do implant these incredibly expensive devices into these very fragile patients, we can do it flawlessly.”

Rosalind Lai, assistant professor of neurosurgery at UB, who was at the time a UB neurosurgery fellow, says she felt privileged to be part of the team. “It was very exciting to be part of this cutting-edge neurosurgery. It was almost like science fiction,” she says. “It’s so remarkable because they implanted the device endovascularly through a catheter in the neck, through the venous system and up into the superior sagittal sinus at the top of the head. Then they threaded the electrode to the motor cortex in the venous sinus system and landed it there precisely.”

The electrode connects to a telemetry device in the patient’s chest.

Levy notes that this trial has provided invaluable lessons for the team that planned and developed the procedure, including neurosurgical residents and fellows at UB.

“Using computer software planning, we pinpointed with submillimeter accuracy precisely where the implantable stent — what we call the neuroprosthetic — will go in the brain,” says Levy. “This is what our residents, fellows and even our students at the Jacobs School get to see in action: medical technology that really doesn’t exist in mainstream medicine yet. It’s part of this whole revolution in AI that’s happening right now.”