There are more than 3.4 million adults and children in the United States with active epilepsy, and about one million of those experience seizures that are unable to be controlled by medicine. To further understand this intractable form of epilepsy, NYU Langone Health has been awarded an $8 million grant from the National Institutes of Health (NIH) to develop a state-of-the-art implantable monitoring device to collect previously unobtainable data on how the brain behaves moments before and during a seizure.
Current technology used to capture brain activity related to epileptic seizure is decades old, and has limited our progress in developing new treatments."
Daniel Friedman, MD, co-director of the electroencephalogram (EEG) laboratory, NYU Langone's Comprehensive Epilepsy Center
"We now have the opportunity to build a new, ultrathin implantable device that can have thousands of measurement contacts instead of dozens," says Dr. Friedman, who is also a professor in the Department of Neurology at NYU Grossman School of Medicine. "There is so much more we will be able to learn about electrical activity in the brain."
The funding, which carries an NIH UG3/UH3 designation indicating innovative development and clinical research, will be shared in partnership with New York University's Center for Neural Science, Duke University, the University of Utah, and Blackrock Neurotech.
Designed by Jonathan Viventi, PhD, assistant professor in the Department of Biomedical Engineering at Duke University, the implant uses a flexible liquid crystal polymer thermoplastic material that seals around a network of circuits connecting hundreds to thousands of electrodes. Prototypes were tested intraoperatively for a period of up to 30 minutes in dozens of patients at both Duke and NYU Langone. A new version of the device for clinical use that can be implanted up to 30 days will now be developed by Duke, the University of Utah, and Blackrock Neurotech.
"Our new, state-of-the-art monitoring device will enable high-density sampling of microsignals from large areas of the brain," says Dr. Viventi, who first began development of the technology 10 years ago as assistant professor of electrical and computer engineering at NYU Tandon School of Engineering. "With this tool we will be able to capture a high-definition picture of what's really happening in the brain moments before epileptic seizures."
Bijan Pesaran, PhD, professor of neural science at NYU, collaborated with Dr. Viventi since 2011 and 2012 on the proof of concept for the novel implantable brain electrode array using microfabricated technology.
"With effective neurotechnology that can monitor—as well as stimulate—the brain, we may be able to develop new treatments for comorbidities related to diseases we still do not fully understand," said Dr. Pesaran. "There has not been a new implantable technology for epilepsy developed since the 1980s. With this microscale device the sky's the limit on what we can learn and it could transform the patient care model."
Blackrock Neurotech, based in Salt Lake City, is the leader in brain-computer interface technology and recently received the U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for an innovative, first-of-its-kind system that provides immobile patients with the ability to control a variety of prosthetic devices and computing tools, including mouse cursors, keyboards, and mobile devices, simply by thinking.
"NYU Langone Health is the ideal partner for advancing a tool to better understand the brain's function and provide meaningful treatments that can dramatically improve the quality of life for people with epilepsy," says Marcus Gerhardt, co-founder and CEO of Blackrock Neurotech. "We will work closely with researchers at the University of Utah and the FDA to prioritize patient safety and quality as we bring this technology to market."
Florian Solzbacher, PhD, professor and chair of the Department of Electrical and Computer Engineering at the University of Utah, and co-founder, president, and executive chairman of Blackrock Neurotech, will oversee initial device testing and compliance with FDA regulations before the clinical research phase.
"This partnership could lead to a paradigm shift—a major step forward in terms of precision treatment," says Dr. Solzbacher. "The high-definition data collection will give a boost to furthering development of laser ablation and high-precision surgeries to dramatically improve epilepsy outcomes."
Clinical trials using an FDA-approved monitoring implant are expected to begin at NYU Langone Health in 2023. The funding award is from NIH's Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which is aimed at revolutionizing our understanding of the human brain.
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