Breakthrough UC San Diego Brain Recording Device Receives FDA Approval for a Clinical Trial

The AHA! Team — Fri, 02 Aug 2024 08:21:00 +0000

University of California San Diego via Newswise – The Federal Drug Administration approved a clinical trial to test the effectiveness of an electronic grid that records brain activity during surgery, developed by engineers at the University of California San Diego. The device with nanoscale sensors records electrical signals directly from the surface of the human brain in record-breaking detail. The grid’s breakthrough resolution could provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy. The grid’s higher resolution for recording brain signals could improve neurosurgeons’ ability to minimize damage to healthy brain tissue. 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. The new brain sensor array, known as platinum nanorod grid (PtNRGrid) features a densely packed grid of a record-breaking 1,024 embedded electrocorticography (ECoG) sensors. The device rests on the surface of the brain and is approximately 6 microns thin–smaller than one tenth of the human hair–and flexible. As a result, it can both adhere and conform to the surface of the brain, bending as the brain moves while providing high-quality, high-resolution recordings of brain activity. In contrast, the ECoG grids most commonly used in surgeries today typically have between 16 and 64 sensors. These grids are rigid, stiffer and more than 0.5 mm in thickness and do not conform to the curved surface of the brain. The PtNRGrid was invented by Shadi Dayeh, a Professor in the Department of Electrical and Computer Engineering at the University of California San Diego and members of his team. Over the years, the team developed the PtNRGrid technology 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,” 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) for a “pivotal study [titled] “Systematic Evaluation of Platinum Nanorod Grids (PtNRGrids) for Intraoperative Mapping and Neurophysiological Monitoring (IONM) During Brain Surgeries.” Specifically, the clinical trial is designed to demonstrate the effectiveness of the PtNRGrid device to map both normal and pathological brain activity. During the trial, UC San Diego engineers will partner with clinician-scientists: Drs. Sharona Ben-Haim and Eric Halgren at UC San Diego, Dr. Sydney Cash at MGH, and Dr. Ahmed Raslan at OHSU. In a first phase, 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. Record-breaking density Dayeh’s team has pioneered human brain and spinal cord mapping with thousands of channels since 2019, and has reported early safety and efficacy results in a series of articles published in Science Translational Medicine in 2022 in human subjects. PtNRGrid is the only device with thousands of channels to demonstrate in peer-reviewed publications that it can map motor and language brain activity, as well as epileptic discharges, by producing panoramic videos of brain waves over 10 square centimeters of the brain’s cortex while maintaining resolution at a microscopic level. Currently, Dayeh’s research group holds the world record of recording brain activity from a single cortical grid with 2,048 channels on the surface of the human brain published in Science Translational Medicine in 2022. The device was used in the operating room of Dr. Ahmed Raslan of the OHSU. Since then, the team has increased the number of recording channels to 4,096 and continues to work on increasing the number of channels in the grid to monitor brain activity in even higher resolution. Pending success of this staged trial, the team will transition to the next crucial step of making the PtNRGrid available for commercial use at scale. Demonstrating that ECoG grids with sensors in the thousands of channels record brain activity with high fidelity also opens new opportunities in neuroscience for uncovering a deeper understanding of how the human brain functions. Basic science advances, in turn, could lead to improved treatments grounded in enhanced understanding of brain function. “Our goal is to provide a new atlas for understanding and treating neurological disorders, working with a network of highly experienced clinical collaborators at UC San Diego, MGH, and OHSU,” Dayeh said. Dayeh’s work toward the FDA approval is supported by an NIH BRAIN® Initiative award # UG3NS123723. To read the original article click here.

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Study Detects Abnormally Low Levels of a Key Protein in Brains of Young Men with Autism

AHA Publisher — Wed, 26 Feb 2020 08:00:10 +0000

Massachusetts General Hospital via EurekAlert – Using cutting-edge imaging technology, researchers at Massachusetts General Hospital (MGH) have shown that the brains of young men with autism spectrum disorder (ASD) have low levels of a protein that appears to play a role in inflammation and metabolism. BOSTON – This surprising discovery, which published online today in the journal Molecular Psychiatry provides an important new insight into the possible origins of ASD, which affects one in 59 children. ASD is a developmental disorder that emerges in early childhood and is characterized by difficulty communicating and interacting with others. While the cause is unknown, growing evidence has linked ASD to inflammation of brain tissue, or neuroinflammation. One sign of neuroinflammation is elevated levels of a substance called translocator protein (TSPO), which can be measured and located in the brain using positron-emission tomography (PET) and anatomical magnetic resonance imaging (MRI). The MGH study, led by Nicole Zurcher, PhD, an investigator in MGH’s Athinoula A. Martinos Center for Biomedical Imaging, was the first to use a new generation of PET “tracers,” which more accurately detect TSPO, to examine the brains of people with ASD. In the study, Zurcher and her colleagues scanned the brains of 15 young adult males (average age, 24) with ASD. The group included both high- and low-functioning subjects with varying degrees of intellectual abilities. For comparison, Zurcher’s team scanned the brains of 18 healthy control subjects who were similar in age. The investigators hypothesized that the scans would show increased levels, or expression, of TSPO in subjects who have ASD. “To our surprise, that’s not what we saw,” says Zurcher. Instead, the scans showed that the brains of males with ASD had lower levels of TSPO than those of the healthy subjects. In fact, the men with the most severe symptoms of ASD tended to have the lowest expression of TSPO. When the tests were repeated several months later, the pattern persisted. The brain regions found to have low expression of TSPO have previously been linked to ASD in earlier studies, and are believed to govern social and cognitive capacities such as processing of emotions, interpreting facial expressions, empathy, and relating to others. “We know these brain regions are involved in autism,” says Zurcher. To understand this unexpected finding, Zurcher notes that TSPO does more than serve as a marker of inflammation. “It has multiple complex roles,” she says, and some actually promote brain health. For example, adequate TSPO is necessary for normal functioning of mitochondria, which are the “power houses” in cells that produce energy. Earlier research has linked malfunctioning mitochondria in brain cells to ASD. Zurcher and her colleagues next plan to study brains from deceased donors with the goal of determining which brain cells in people with ASD might experience mitochondrial dysfunction, which she says may well be occurring alongside neuroinflammation and other mechanisms to cause ASD. “Our study has generated new hypotheses that now need to be investigated,” says Zurcher. “There’s more work to be done.” To read the original article click here.

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Breakthrough UC San Diego Brain Recording Device Receives FDA Approval for a Clinical Trial

Study Detects Abnormally Low Levels of a Key Protein in Brains of Young Men with Autism