EPITEL, INC — Department of Health and Human Services SBIR Phase II: 105

Description

ABSTRACT The EEG PatchTM is a single channelelectrodewearablepatch like device designed for long termEEG recording in people with epilepsy to be used in their everyday environmentTo maximize the treatment of epilepsyit is critical to capture important day to day changes in EEG activity for long periods including the occurrence and duration of epileptiform events such The EEG Patch is unobtrusive and placed as spike wave discharges and seizuresHaving access to a more on the scalp by an epileptologist where complete record of a person s seizures may improve the treatment seizures are known to manifestElectrode strategy to balance the side effects of anti seizure medication with spacing follows standard high density seizure controlDue to a lack of long term EEG dataclinicians are wired EEGforced to rely on seizure diariesa method of self reporting seizures that has been shown to be inaccurate and often misleadingsimply because the person does not realize they have had a seizureAn unobtrusiveat homeweekly EEG monitoring device capable of counting seizurescould revolutionize clinical diagnoses and therapeutic actions for people living with epilepsyThe EEG Patch is designed to be used after traditional EEG has determined where seizures begin or generalize so as to provide the optimal location sfor recording when seizures occurseizure countingThere is currently no device that can provide clinicians with a long term quantitative report of a person s EEG seizures suitable for athome monitoring in their everyday environment that is not diary basedThe EEG Patch is a wirelesschannelelectrodedifferentially amplified transmitter and data loggercapable of recording EEG fordaysThe EEG Patch drawsmAmWand is powered by a single lithium primary batteryThe unique robust design provides users with complete mobility in daily activities such as bathing and sleep during EEG monitoringcritical for patient adoptionAfter a week of recordingthe EEG Patch is returned to Epitel where a personalized report of EEG activity is archived in the user s electronic medical recordsIn Phase IEpitel demonstrated a critical enabling clinical capability in a feasibility study of the EEG Patch in the epilepsy monitoring unitA well placedsingle channel EEG Patch can be used to count seizures just as accurately as the andquot goldstandardandquotwired EEG Seizure recording from Epitel s single channel EEG Patch in the epilepsy long term monitoring unit at the University of ColoradoTraces are EEG from a patient admitted for video EEG monitoring as standard of careThe EEG Patch was placed between wired electrodes and the seizure verified with full montage reviewThe long term goal is for the EEG Patch to become theat homeseizure counting standard as the only device capable of recording convulsiveclinicaland non convulsivesubclinicalseizuresIn Phase IIEpitel willDevelop a semi automated EEG seizure extraction tool that reduces the time it takes for expert visualreview of EEG fromdays to andlth using a custom GUI for seizure countingTake the EEG Patch out of the clinic and in the user s home for a final feasibility studyThird party testing of biocompatibilityelectrical safetyand medical package sterilityGain feedback from a pre submission meeting with FDA prior to clinical validationClinical EEG Patch validation in adults and children with epilepsyPost hoc validation of the seizure review software with EEG Patch single channel EEG The simplicity of the EEG Patch makes it easier to obtain a more completequantitative EEG record that identifies a history of a patient s seizures with more accuracy than self reportingThe EEG Patch could improve patientphysician interaction that could make a profound change in the personalized treatment of epilepsy This grant proposal aims to validate a miniaturechannelelectrodewearable EEG patch for recording when seizures occur overdays to help improve the treatment of people with epilepsyThe device stays attached to the scalp allowing complete mobility in daily activities including bathing and sleepThe long term goal is to develop a clinical tool for counting seizures to augment an individual s seizure diary