Watch as Benjamin I. Rapoport, MD, PhD, Co-Founder of Precision Neuroscience, and a pioneer in neurotechnology, and Joshua B. Bederson, MD, Chair of Neurosurgery at Mount Sinai, discuss the BCI Layer 7 Cortical Interface as they provide an operating room perspective.
The technology converts biological neural signals to digital bits, then uses machine learning to “decode” digitized neural signals. It is being used on an investigational basis, through abbreviated investigational device exemptions (IDEs) or nonsignificant risk IDEs, under local institutional review board approval, and with the informed consent of the patients involved.
For this study, the technology being used is the Layer 7 Cortical Interface, developed by Precision Neuroscience. It contains 1,024 tiny electrodes spanning an area of 1.5 square centimeters, embedded in a flexible film that conforms to the brain’s surface. The film is one-fifth the thickness of a human hair and was designed to be implanted and removed by neurosurgeons without damaging brain tissue.
“Ultimately, BCI technology is meant to function as a digital bypass for patients with certain forms of paralysis, including from spinal cord injury, amyotrophic lateral sclerosis, brainstem stroke, hemorrhages in the subcortical white matter, and a variety of other conditions in which the neocortex remains intact,” says Benjamin I. Rapoport, MD, PhD.
Precision Neuroscience was co-founded by Dr. Rapoport, where he also serves as its Chief Science Officer. Dr. Rapoport is Assistant Professor of Neurosurgery at Icahn Mount Sinai and a practicing neurosurgeon who has a PhD in electrical engineering and computer science. He also serves as the Scientific Director of Mount Sinai BioDesign, a medical technology prototyping center and incubator housed within the Mount Sinai Health System.
Dr. Rapoport has a track record of technology translation in the areas of digital health, including serving as co-founder of Simbionics (acquired by Apple), and neurotechnology, including serving as a co-founding member of Neuralink.
“As one of the leading sites participating in the trials for the new electrode array, we are eager to see what we will learn from the detailed information we will collect and analyze,” says Joshua B. Bederson, MD, the Leonard I. Malis, MD/Corinne and Joseph Graber Professor of Neurosurgery and Chair of Neurosurgery for the Mount Sinai Health System and Executive Director of Mount Sinai BioDesign.
As part of the open-label, single-arm feasibility study, Dr. Bederson and several other study investigators are temporarily placing the investigational device on the surface of the study participants’ brains during intracranial procedures where surface mapping is routinely performed and correlated to evoked potentials or standardized behavioral tasks that are routinely performed as part of these procedures. The device records high resolution electrophysiological signals and the data collected is compared to that obtained using standard-of-care cortical surface arrays.
In 2022, separate from this study—and among other accomplishments in the field—Mount Sinai was the first institution in the United States to implant a patient with the Stentrode, a small BCI device that is implanted through blood vessels in the brain, using a minimally invasive approach that does not require open brain surgery. The procedure was coordinated by Thomas J. Oxley, MD, PhD, Clinical Instructor of Neurosurgery and Director of Innovation at Mount Sinai BioDesign, and Co-Founder and Chief Executive Officer of Synchron, the manufacturer of the Stentrode. Shahram Majidi, MD, Assistant Professor of Neurosurgery, performed the procedures to implant the devices into the study participants’ brains as part of a National Institutes of Health-funded clinical trial.
Dr. Bederson is Chair for the Department of Neurosurgery at the Mount Sinai Health System. Drs. Rapoport and Oxley are faculty members in the Department of Neurosurgery. Dr. Bederson serves in a supervisory role for them within the Health System. Dr. Rapoport is an equity owner in Precision Neuroscience, serves as its Chief Science Officer, and is a member of its board of directors. Neither Dr. Bederson nor Mount Sinai has a financial interest in Precision Neuroscience. Dr. Oxley is an equity owner in Synchron, serves as its Chief Executive Officer, and is a member of its board of directors. Dr. Bederson and other faculty members at Mount Sinai are equity owners in Synchron. All Precision Neuroscience and Synchron research at Mount Sinai is conducted by investigators without financial ties to either company.