MOUNTAIN VIEW, Calif., Feb. 13, 2020 /PRNewswire/ -- Ceribell, Inc. announced the results of a study, led by Dr. Brandon Westover, a leading expert in the field of electroencephalography (EEG) and brain monitoring at Massachusetts General Hospital, Harvard Medical School, that confirms reduced array EEG systems like the one used by the Ceribell Rapid Response EEG System, meet the gold standard for detection of seizures. The study, which assessed 212 patient recordings, confirmed that an EEG configuration with 10 electrodes around the head (without electrodes in the parasagittal and midline regions) yields high diagnostic concordance (95%) and high agreement between EEG-readers (93%).
This study is an important step forward in confirming the diagnostic utility of easy to use and rapid EEG systems like the Ceribell system because it shows in a systematic way that these systems do fair very well compared to gold standard conventional EEG.
"We are excited to see the growing body of evidence supporting the accuracy and utility the Ceribell Rapid Response EEG system for use in critical care situations where time to diagnosis is essential for making treatment decisions and improving patient outcomes," said Dr. Josef Parvizi, co-founder and Chief Medical Advisor, Ceribell.
Non-convulsive seizures, including non-convulsive status epilepticus (NCSE), are common in critically ill patients. 90% of these seizures are non-convulsive and can only be detected by EEG. Prolonged non-convulsive seizures lead to permanent brain injury, and delayed diagnosis and treatment of NCSE leads to higher morbidity, mortality, and length of hospital stay. As a result, the current guidelines from the Neurocritical Care Society recommend that continuous EEG should be initiated within 15-60 minutes of suspected status epilepticus in all patients. However, meeting this guideline has proven difficult due to limitations of conventional EEG systems. The Ceribell Rapid Response EEG system was developed to address limitations in EEG acquisition and interpretation.
Conventional EEG systems with more electrodes are the gold standard for monitoring of brain activity. However, the diagnostic utility of the midline and parasagittal electrodes in the evaluation of epileptic activity has not been thoroughly addressed. Past literature has suggested discordance between conventional and reduced montage EEG systems in the detection of epileptic discharges, but these studies had significant limitations because they did not consider variability between EEG-readers or mitigate the effects of unequal access to ancillary information.
This study sought to retrospectively review EEG data from 212 patients to: (1) assess the diagnostic concordance between conventional EEG versus a reduced montage system, and (2) measure the accuracy of reduced montage EEG compared to a full montage system when the effects of these confounding factors are mitigated.
"A device like the Ceribell Rapid Response EEG has the potential to reliably detect seizure activity and improve the care of critically ill patients. As we continue to drive innovation in the field of encephalography, we are excited to share these results and the encouraging results from our multi-center clinical trial, further building the evidence around the accuracy and utility of our Rapid Response EEG system," said Jane Chao, CEO, Ceribell.
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ABOUT THE CERIBELL RAPID RESPONSE EEG SYSTEM
The Ceribell Rapid Response EEG System consists of a 10-electrode (8-channel) headband, an EEG recorder with Brain Stethoscope feature, and a cloud portal for storing and reviewing EEGs. This simplified configuration of EEG enables easy access to EEG within minutes.
The Ceribell EEG System received FDA 510(k) clearance in 2017 and is commercially available in the United States.
Ceribell, Inc. (www.ceribell.com), is headquartered in Mountain View, CA. Ceribell is focused on making EEG widely available, more efficient, and more cost-effective to improve the diagnosis and treatment of patients at risk for seizures.
SOURCE Ceribell, Inc.