Breakthrough Brain Recording Device Gains FDA Approval for Clinical Trial

The FDA has approved a clinical trial to test an electronic grid that records brain activity during surgery. The grid was developed by engineers at the University of California San Diego.
 
The device contains nanoscale sensors that record electrical signals directly from the surface of the human brain in record-breaking detail. The brain sensor array is known as a platinum nanorod grid (PtNRGrid) and features a densely packed grid of 1,024 embedded electrocorticography (ECoG) sensors. 
 
Shadi Dayeh, a Professor in the Department of Electrical and Computer Engineering at the University of California San Diego, and members of his team invented the PtNRGrid. The technology was developed in collaboration with neurosurgeons and medical researchers from UC San Diego, Massachusetts General Hospital (MGH), and Oregon Health & Science University (OHSU).
 
The device rests on the surface of the brain and is approximately 6 microns thin and flexible so it can adhere and conform to the surface of the brain. Since the device can bend as the brain moves it can provide high-quality, high-resolution recordings of brain activity.
 
The grid could provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy. During epilepsy surgery, the novel grid could improve the ability to precisely identify the regions of the brain where epileptic seizures originate for safe and effective treatment.
 
“This accomplishment ushers in a new era of clinical neuroscience and neuromonitoring,” Dayeh said. “We are very excited to receive the FDA approval to apply our groundbreaking PtNRGrid in a clinical setting. It is a credit to the hard work of my team members who worked tirelessly to meet the quality criteria mandated by the FDA. I am also grateful to my clinical partners, the support of the NIH, and to the campus leadership that fostered an impactful ecosystem across engineering and medicine to transform the future of healthcare.”
 
The FDA approved an investigational device exemption (IDE) designed to demonstrate the effectiveness of the PtNRGrid device in mapping normal and pathological brain activity. 
 
In the first phase of the trial, surgeons will implant the PtNRGrid in 20 patients, then measure and compare the grid’s performance with the present state-of-the-art. The PtNRGrid will be deployed in surgeries to remove brain tumors and to remove tissue that causes epileptic seizures.
 
After the trial, the team hopes to make PtNRGrid available for commercial use.