University of California, San Diego receives FDA approval for clinical trial of brain recording device

PtNGrid contains thin, flexible, and densely packed grids consisting of 1024 or 2048 embedded electrocorticography (ECoG) sensors. (David Baillot/UC San Diego Jacobs School of Engineering)

SAN DIEGO (FOX 5/KUSI) – Engineers at the University of California, San Diego have developed an electronic grid to record brain activity during surgery.

The device, known as a platinum nanorod grid (PtNRGrid), has received approval for clinical trials from the Federal Medicines Agency, the university said in a press release on Monday.

According to the university, PtNRGrid features a record 1,024 embedded electrocorticography (ECoG) sensors, compared to typical ECoG grids that have 16 to 64 sensors used in medical offices. The device’s nanosensors record electrical signals directly from the surface of the human brain.

“The device rests on the surface of the brain and is about 6 microns thick – less than one-tenth of a human hair – and flexible. As a result, it can both adhere to and conform to the surface of the brain, flexing as the brain moves, while providing high-quality, high-resolution recordings of brain activity,” said the University of California, San Diego.

According to the university, PtNRGrid, invented by Shadi Dayeh, is intended to provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy.

“This achievement ushers in a new era of clinical neuroscience and neuromonitoring,” Dayeh said. “We are very excited to receive FDA approval for use of our breakthrough PtNRGrid in the clinical setting. This is due to the hard work of my team members who have worked tirelessly to meet the quality criteria required by the FDA. I am also grateful to my clinical partners, NIH support, and campus leadership who have created an influential ecosystem in engineering and medicine to transform the future of health care.”

According to UCSD, the first phase of the clinical trial will involve surgeons implanting the PtNRGrid in 20 patients, then measuring and comparing the performance of the mesh with the current state of knowledge.