EPITEL, INC — Department of Health and Human Services SBIR Phase I: 106

Description

ABSTRACT The EEG PatchTM is a single channel electrode wearable patch like device designed for long term EEG recording in people with epilepsy to be used in their everyday environment To maximize the treatment of epilepsy it is critical to capture important day to day changes in EEG activity for long periods including the occurrence and duration of epileptiform events such as spike wave discharges and seizures Having access to a more complete record of a person s seizures may improve the treatment strategy to balance the side effects of anti seizure medication with seizure control Due to a lack of long term EEG data clinicians are forced to rely on seizure diaries a method of self reporting seizures that has been shown to be inaccurate and often misleading simply because the person does not realize they have had a seizure An unobtrusive at home weekly EEG monitoring device capable of counting seizures could revolutionize clinical diagnoses and therapeutic actions for people living with epilepsy The EEG Patch is designed to be used after traditional EEG has determined where seizures begin or generalize so as to provide the optimal location s for recording when seizures occur seizure counting There is currently no device that can provide Epitel s EEG PatchTM | Long clinicians with a long term quantitative report of a person s seizures term EEG recording of seizure suitable for at home monitoring in their everyday environment that is occurrence for everyday use not diary based Epitel will address this need in a Phase I feasibility study of the EEG Patch in the EEG long term monitoring unit to address a specific enabling clinical capability A well placed single channel EEG Patch can be used to count seizures just as accurately as the andquot gold standardandquot wired EEG Epitel has developed its functional prototype EEG Patch a wireless channel electrode differentially amplified transmitter and data logger capable of recording EEG for days The EEG Patch draws mA mW and is powered by a single lithium primary battery CR mAh The unique robust design will provide users with complete mobility in daily activities The EEG Patch is unobtrusive and placed such as bathing sports and sleep during EEG monitoring critical on the scalp by an epileptologist where for patient adoption After a week of recording the EEG Patch is seizures are known to manifest Electrode returned to Epitel where a personalized report of EEG activity will spacing follows standard high density be provided to both the user and the user s epileptologist wired EEG Seizure recording from Epitel s single channel EEG Patch in the epilepsy long term monitoring unit at the University of Colorado Traces are EEG from a patient admitted for video EEG monitoring as standard of care The EEG Patch was placed between wired electrodes and the seizure verified with full montage review The gateway to commercialization of the EEG Patch will be showing that a channel electrode device can record location specific seizure data as well as the gold standard wired EEG for up to days The long term goal is for the EEG Patch to become the at home seizure reporting counting standard The simplicity of the EEG Patch makes it easier to obtain a more complete quantitative EEG record that identifies a history of a patient s seizures with more accuracy than self reporting The EEG Patch could improve patient physician interaction that could make a profound change in the personalized treatment of epilepsy This grant proposal aims to demonstrate feasibility of miniature channel electrode wearable EEG patch for recording when seizures occur over days to help improve the treatment of people with epilepsy The device stays attached to the scalp allowing complete mobility in daily activities including bathing and sports The long term goal is to develop a clinical tool for counting seizures to augment an individual s seizure diary