SBIR-STTR Award

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 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 "gold- standard" wired EEG Epitel has developed its functional prototype EEG Patch, 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 (CR2330, 265 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 1-channel, 2-electrode device can record location-specific seizure data as well as the gold standard wired EEG for up to 7 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.

Public Health Relevance Statement:
This grant proposal aims to demonstrate feasibility of miniature, 1-channel (2-electrode) wearable EEG patch for recording when seizures occur over 7 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.

Project Terms:
Address; Adoption; Adverse effects; Applications Grants; arm; base; Bathing; Benchmarking; biomaterial compatibility; Businesses; Clinical; clinical Diagnosis; Colorado; commercialization; Computerized Medical Record; Data; density; design; Detection; Development; Device Designs; Devices; Diagnosis; diaries; Electrodes; Electroencephalography; Electronics; Environment; Epilepsy; Equilibrium; Event; Family; Feasibility Studies; Freedom; Goals; Gold; head-to-head comparison; high standard; Home environment; Hospitals; improved; Individual; Legal patent; Letters; Life; Lithium; Location; Medical; Methods; Modeling; Monitor; monitoring device; Morphologic artifacts; Movement; Patient Self-Report; Patients; personalized medicine; Persons; Pharmaceutical Preparations; Phase; Physicians; Plague; Process; prototype; Recording of previous events; Records; Reporting; Research; Rodent Model; Scalp structure; Seizures; Services; Sleep; Sports; standard of care; Subclinical Seizures; System; Technology; Testing; Therapeutic; Time; tool; treatment strategy; Universities; Validation; Wireless Technology

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.

Public Health Relevance Statement:
This grant proposal aims to validate a miniature, 1-channel (2-electrode) wearable EEG patch for recording when seizures occur over 7 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 sleep. The long-term goal is to develop a clinical tool for counting seizures to augment an individual’s seizure diary.

Project Terms:
Adhesives; Adoption; Adult; Adverse effects; Applications Grants; Archives; base; Bathing; biomaterial compatibility; Businesses; Child; Clinic; Clinical; clinical Diagnosis; Clinical Trials; Colorado; Computer software; Computerized Medical Record; Custom; Data; density; design; Development; Device Designs; Devices; Diagnosis; diaries; Docking; Electrodes; Electroencephalography; Electronics; Engineering; Environment; Epilepsy; Equilibrium; Event; Feasibility Studies; Feedback; Freedom; Goals; Gold; high standard; Home environment; improved; Individual; Legal patent; Lithium; Location; Medical; Medical Device; meetings; Methods; Modeling; Monitor; monitoring device; Morphologic artifacts; Movement; Patient Self-Report; Patients; personalized medicine; Persons; Pharmaceutical Preparations; Phase; Physicians; Plague; Protocols documentation; Recording of previous events; Reporting; Safety; Scalp structure; Seizures; Services; Signal Transduction; Sleep; standard of care; Sterility; Subclinical Seizures; Technology; Testing; Therapeutic; Time; tool; Universities; usability; Validation; Visual; Wireless Technology; Work