Ewear Technologies, LLC — Department of Health and Human Services SBIR Phase I: 106

Description

TitleLeadless EEG Sensor for Emergency Medicine AbstractMany patients arriving at the Intensive Care UnitICUare in the state of coma due to a severe injury or diseaseAmong these patientsNon Convulsive SeizuresNCSand Non Convulsive Status EpilepticusNCSEare critical neurophysiological conditions which may not have overt clinical signsThese conductions can be diagnosed only with EEG monitoringStudies have shown that approximatelyandof the critically ill patients in the ICU have NCS and NCSE respectivelyProlonged NCS and NCSE can lead to permanent brain injuryGuidelines published by Neurocritical Care Society require EEG withinminutes after status epilepticusSEare suspectedAlthough many ICUs have been using EEG to diagnose NCS and NCSEunfortunatelyonly approximatelyof the emergency department in the US have EEG technicians available constantlyclearly underdiagnosing the problemIn additionthe time to install EEG electrodes in the standardconfiguration takes aboutminutes by a trained EEG specialistIn the emergency departmenton averageit takeshours to obtain and interpret an EEGPrimary reasons for this time consuming procedure aresetting up EEG equipment in busyhuman resource constrained ICU is currently a complex procedureinstalling electrodes on the scalp of patients is time consumingEEG leads interfere with critical care proceduresandloose electrodes cause noise or interruption in data collectionAs the result of these technical problemsEEG study is commonly conducted only after the patient s condition is stabilizedThis implies a miss of possibly important diagnostic information during early portions of emergency care proceduresincluding those at the site of injuryduring patient transportationand during initial injury management in the ICUThis miss of monitoring and diagnostic opportunities may result in seriouspossibly life threatening consequencesIn order to solve these problems and comply with the unique point of care environmentwe will develop a novel EEG acquisition deviceThis device is a self contained EEG sensor in the size of a U Spenny that is miniatureleadless and single unitreducing the clinical EEG practice from a complex procedure to a simple twist on the scalpBy simply pressing the EEG sensor against the unprepared scalp and twisting slightlythe device can grasp the skin firmly and start acquiring and transmitting EEG wirelessly to a bedside monitora smartphoneor a Bluetooth enabled device in emergency departmentsAlthough the new EEG sensor will not replace the traditionalfull montage EEG study currently conducted at a non emergency settingit will allow acquisition of EEG at one or several scalp sites quickly during emergency care to assess the neurological status of patientswhich has a significant diagnostic value and will save livesOur research team includes three engineers and two medical doctors who practices in the ICUThe investigators hold three patents on a novel dry electrode which will be used as the basic structure of our proposed sensorIn this PhaseSBIR projectwe will improve the electrode of the new EEG sensordesign electronic circuitry that can be fit within the body of the sensorand prove the feasibility of the new sensor by conducting a validation study on human subjectsAfter the completion of this projectwe will firmly prove the feasibility of the new leadlesssingle unit and penny sized EEG sensor for its further development in PhaseSBIR Narrative Many patients arriving at the Intensive Care UnitICUare in the state of coma due to a severe injury or diseaseAmong these patientsmany develop dangerous hidden seizures that can only be detected by continuous electroencephalographicEEGrecordingHoweverthe current EEG measurement is too timeconsumingnot suitable for use in the ICUThis bioengineering project will develop a new EEG sensor to solve this clinical problem