Low-Cost, Portable, Point of Care Amplitude-Integrated Electroencephalography (aEEG)

Period of Performance: 07/01/2015 - 06/30/2016

$225K

Phase 1 SBIR

Recipient Firm

Advanced Medical Electronics Corporation
MAPLE GROVE, MN 55369
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): The goal of this project is to develop a portable, low-cost tool to aid in the diagnosis, intervention and improvement of outcomes for neonates born with neurologic complications. The project will develop instrumentation technology to enable early detection of neurologic brain injury and seizure activity for newborns delivered in care facilities that lack a full suite of neurological diagnostic tools. In neonates with birth asphyxia seizures are very common and most frequently subclinical. Many studies have observed that even experienced clinicians have difficulty correctly identifying seizures in this population. Subsequently, clinical paroxysms that do not truly represent seizure are frequently over-treated and subclinical seizures, including status epilepticus, go unrecognized and untreated. As such, the use of continuous video- electroencephalograph (EEG) monitoring is the gold standard for recognizing and treating seizures in this population. It is also very helpful at identifying which children have sustained brain injury, including hypoxia. This resource intense modality has become the standard of care at many tertiary medical centers but unfortunately remains unavailable to many clinicians at smaller birth facilities. Quantitative EEG, including the use of amplitude-integrated EEG (aEEG), has gained widespread use at most neonatal ICUs, and represents a more user-friendly bedside tool for identifying brain injury and seizures. The goal of the phase I project is to specify, design, prototype, and evaluate a low-cost, telemedicine-enabled aEEG monitor that is portable and supports widespread use in smaller facilities. A prototype instrument will be specified, designed, built, and evaluated. The follow-on phase II program will conduct a large human trial.