19.07.2024

The FDA has approved a clinical trial to test the effectiveness of the PtNRGrid, a high-resolution brain recording device developed by engineers at the University of California San Diego. This device could significantly improve brain surgeries by providing detailed recordings of brain activity.

The PtNRGrid boasts a thin, flexible, and densely packed grid of 1,024 or 2,048 embedded electrocorticography (ECoG) sensors. These nanoscale sensors record electrical signals directly from the brain's surface with unprecedented detail. The device's flexibility allows it to conform to the brain's movements, providing high-quality recordings while minimizing damage to healthy brain tissue.

Image: PtNGrid consisting of embedded electrocorticography (ECoG) sensors; Copyright: David Baillot/University of California San Diego

The PtNGrid features thin, flexible and densely packed grids of either 1,024 or 2,048 embedded electrocorticography (ECoG) sensors.

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Key Benefits of PtNRGrid:

High-Resolution Recordings: Captures brain signals with superior clarity.
Flexibility: Conforms to the brain's surface and movements.
Minimized Tissue Damage: Enhances neurosurgeons' ability to protect healthy brain areas.

The PtNRGrid was invented by Professor Shadi Dayeh from the Department of Electrical and Computer Engineering at the University of California San Diego, alongside his team. 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).

"This accomplishment ushers in a new era of clinical neuroscience and neuromonitoring," said Dayeh. "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."

Clinical Trial Overview

The FDA approved an investigational device exemption (IDE) for a pivotal study titled “Systematic Evaluation of Platinum Nanorod Grids (PtNRGrids) for Intraoperative Mapping and Neurophysiological Monitoring (IONM) During Brain Surgeries.” This clinical trial aims to demonstrate the effectiveness of the PtNRGrid in mapping both normal and pathological brain activity.

The PtNRGrid is the only device with thousands of channels that can map motor and language brain activity, as well as epileptic discharges, producing panoramic videos of brain waves over 10 square centimeters of the brain’s cortex while maintaining microscopic resolution.

Pending the success of this staged trial, the team will move towards making the PtNRGrid available for commercial use. Demonstrating that ECoG grids with thousands of sensors can record brain activity with high fidelity opens new opportunities in neuroscience, enhancing our understanding of brain functions and potentially leading to improved treatments for neurological disorders.

MEDICA-tradefair.com; Source: University of California – San Diego

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