Precision Neuroscience Corporation has 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 Rockefeller Neuroscience Institute (WVU RNI; Morgantown, USA), 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—as per a press release.
Precision Neuroscience’s brain-computer interface (BCI) system, which is named the Layer 7 Cortical Interface, contains 1,024 tiny electrodes spanning an area of one square centimetre embedded in a flexible film that conforms to the brain surface. The film is one-fifth as thick as 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.
In the present study, the Layer 7 Cortical Interface was temporarily placed on the brain of a patient undergoing resection of a brain tumour. 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 RNI, two additional patients have undergone similar operations using the Precision Neuroscience system. These required surgeries to remove tumours 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 Neuroscience system is designed to map brain regions responsible for speech production in unprecedented detail.
“While BCIs have been studied for several decades, their potential has not been realised,” said Ali Rezai (WVU RNI, Morgantown, USA). “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,” added Peter Konrad (WVU School of Medicine, Morgantown, USA), the principal investigator leading the study. “It [was] as if I was seeing the patient’s brain think.”
The study—which, in its first phase, will enrol up to five patients—is being performed at WVU RNI under the approval of the West Virginia University Institutional Review Board. Related studies are anticipated at several other major US medical centres, including Mount Sinai Health System in New York City, Penn Medicine in Philadelphia, and Massachusetts General Hospital in Boston.
“Precision technology has the potential to redefine the standard of care in clinical neuroscience,” said Benjamin Rapoport (Mount Sinai Health System, New York City, USA), 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.”
“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 behaviours,” commented Iahn Cajigas (University of Pennsylvania, Philadelphia, USA). “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 the coming months, Precision Neuroscience expects to complete an application to the US Food and Drug Administration (FDA) for its device to be cleared for use in diagnostic electrophysiologic mapping procedures lasting up to 30 days. The company’s recent press release notes, however, that the Layer 7 is an investigational device that is currently not available for sale in the USA.