Precision Neuroscience, a company developing minimally invasive brain-computer interfaces, has completed first-in-human procedures in a pilot clinical study of its neural implant system.
The system, dubbed Layer 7 Cortical Interface, is designed to record and map the brain’s activity in detail, to help restore brain function in people suffering from neurological disorders.
The company is conducting the pilot study in partnership with West Virginia University’s Rockefeller Neuroscience Institute (WVU RNI).
Currently, in the first phase, the study is being conducted at the Rockefeller Neuroscience Institute, with the approval of the WVU RNI, and will enrol up to five patients.
Neurosurgeons at WVU RNI safely deployed the implant onto the brain for reading, recording, and mapping electrical activity from the surface of the brain.
In the study, the Layer 7 Cortical Interface was temporarily placed on the brain of a patient undergoing resection of a brain tumour, said the brain-computer interface developer.
WVU RNI executive chairperson Ali Rezai said: “While brain-computer interfaces have been studied for several decades, their potential has not been realized.
“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.”
RNI department of neurosurgery chairman, and the study principal investigator Peter Konrad said: “This is a remarkable achievement in real-time detection of electrical brain activity mapped with such high resolution. It’s as if I was seeing the patient’s brain think.”
The Layer 7 Cortical Interface contains 1,024 miniature electrodes, packed within one cm² area, embedded in a flexible film that adapts to the brain surface.
Measuring only one-fifth the thickness of human hair, the film is designed to be implanted and removed by neurosurgeons without damaging brain tissue.
The neural implant system is designed to map a large area of the brain’s surface at resolutions hundreds of times more detailed than typical neurosurgical procedures, said the company.
Furthermore, Precision plans to submit an application to the FDA in a few months, seeking regulatory approval of its device, for use in diagnostic electrophysiologic mapping procedures.
Precision Neuroscience chief science officer and neurosurgeon Benjamin Rapoport said: “Precision technology has the potential to redefine the standard of care in clinical 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.”
