The study, in partnership with West Virginia University’s Rockefeller Neuroscience Institute, represents the first time Precision’s electrode technology has been used to map human brain activity. The technology is designed to record brain activity in unprecedented detail.
Brain–computer interface company Precision Neuroscience Corporation announced that the first-in-human procedures in a pilot clinical study of its neural implant system have been successfully completed. In partnership with West Virginia University’s Rockefeller Neuroscience Institute (WVU RNI), a world leader in applying innovative research and technology to improve clinical care, this study was designed to record and map the brain’s activity in unprecedented detail and signals a major step toward the company’s goal of restoring meaningful function to millions of people suffering from neurological illnesses and disorders.
The Precision Neuroscience system, called the Layer 7 Cortical Interface, contains 1,024 tiny electrodes spanning an area of one square centimeter, embedded in a flexible film that conforms to the brain surface. The film is one-fifth the thickness of a human hair and is designed to be implanted and removed by neurosurgeons without damaging brain tissue. The device is engineered to map a large area of the brain’s surface at resolutions hundreds of times more detailed than typical arrays used in neurosurgical procedures.
“Precision technology has the potential to redefine the standard of care in clinical neuroscience,” said Dr. Benjamin Rapoport, a neurosurgeon and the Chief Science Officer at Precision Neuroscience. “In the years ahead, we hope to restore function to people with a number of neurological conditions. Even in these first patients, we have begun to view human brain activity in ways that have never before been possible.”
During this study, the Layer 7 Cortical Interface was temporarily placed on the brain of a patient undergoing resection of a brain tumor. Neurosurgeons at WVU RNI safely deployed the implant onto the brain for a portion of the surgery—reading, recording, and mapping electrical activity from the surface of the brain.
Since the first procedure, completed in mid-April at the RNI, two additional patients have undergone similar operations using the Precision system. These required surgery to remove tumors involving brain regions responsible for language. A portion of each of these operations was performed with the patients awake, in order to identify critical language areas in real time. In settings such as these, the Precision system is designed to map brain regions responsible for speech production in unprecedented detail.
“While brain–computer interfaces have been studied for several decades, their potential has not been realized,” said Dr. Ali Rezai, Executive Chair of WVU RNI. “Innovations such as this from Precision Neuroscience are a key step forward. We look forward to continuing this important research to advance this field and disseminate this technology to help our patients.”
“This is a remarkable achievement in real-time detection of electrical brain activity mapped with such high resolution,” said Dr. Peter Konrad, Chairman of the Department of Neurosurgery at the RNI, and the principal investigator leading the study at West Virginia University Medicine in collaboration with Precision Neuroscience. “It’s as if I was seeing the patient’s brain think.”
The study, which in its first phase will enroll up to five patients, is being performed at the Rockefeller Neuroscience Institute under the approval of the West Virginia University Institutional Review Board. Related studies are anticipated at several other major medical centers, including Mount Sinai Health System in New York City, Penn Medicine in Philadelphia, and Massachusetts General Hospital in Boston.
Neurosurgeons are optimistic about promising studies and advances within brain–computer interface technology.
“Having the ability to record brain activity at such a detailed spatial and temporal resolution will allow us to refine our understanding of how the brain coordinates complex behaviors,” said Dr. Iahn Cajigas, a functional neurosurgery and epilepsy neurosurgeon at the University of Pennsylvania. “Ultimately, this level of functional detail along with the large amount of data obtained will allow for cutting-edge, data-driven methods to decode and potentially restore brain functions.”
In coming months, the company expects to complete an application to the FDA for its device to be cleared for use in diagnostic electrophysiologic mapping procedures lasting up to 30 days.
The Layer 7 is an investigational device that is not available for sale in the United States.
About Precision Neuroscience
Precision Neuroscience is working to provide breakthrough treatments for the millions of people worldwide suffering from neurological illnesses. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large amounts of data. To learn more about how Precision is connecting human intelligence and artificial intelligence, visit www.precisionneuro.io.
