EEG Patch

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ABSTRACT The EEG PatchTM is a single channel, (2 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 The EEG Patch is unobtrusive and placed as spike-wave discharges and seizures. Having 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 manifest. Electrode strategy to balance the side-effects of anti-seizure medication with spacing follows standard high-density seizure control. Due to a lack of long-term EEG data, clinicians are wired EEG. 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 clinicians with a long-term quantitative report of a person’s EEG seizures suitable for at- home monitoring in their everyday environment that is not diary-based. The EEG Patch is a wireless 1 channel (2 electrode) differentially amplified transmitter and data logger, capable of recording EEG for 7 days. The EEG Patch draws 1.14 mA (3.42 mW) and is powered by a single lithium primary battery. The unique robust design provides users with complete mobility in daily activities such as bathing and sleep during EEG monitoring, critical for patient adoption. After a week of recording, the EEG Patch is returned to Epitel where a personalized report of EEG activity is archived in the user’s electronic medical records. In Phase I, Epitel demonstrated a critical enabling clinical capability in a feasibility study of the EEG Patch in the epilepsy monitoring unit:  A well-placed, single-channel EEG Patch can be used to count seizures just as accurately as the "gold- standard" 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 long-term goal is for the EEG Patch to become the ‘at-home’ seizure counting standard as the only device capable of recording convulsive (clinical) and non-convulsive (subclinical) seizures. In Phase II, Epitel will:  Develop a semi-automated EEG seizure extraction tool that reduces the time it takes for expert visual review of EEG from 7 days to <2 h using a custom GUI for seizure counting  Take the EEG Patch out of the clinic and in the user’s home for a final feasibility study.  Third party testing of biocompatibility, electrical safety, and medical package sterility  Gain feedback from a pre-submission meeting with FDA prior to clinical validation  Clinical EEG Patch validation in adults and children with epilepsy  Post-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 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.