The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures. The device continuously records brain, cardiorespiratory, and physical activity data. The study aims to 1) collect benchmark data for seizure detection algorithm development and validation, and 2) evaluate the performance of the device in clinical and at home workflows. Participants will wear the device during a routine Epilepsy Monitoring Unit (EMU) admission. Additionally, they can continue wearing the device at home after the EMU admission.
Epilepsy, a neurological disorder characterized by recurrent epileptic seizures of often complex etiology, affects 65 million people globally. The current reference for home use is self-reported outcomes (typically via a seizure diary) which leads to significant under and inaccurate reporting of seizures. As seizure counting is the basis for many medical decisions, the ability to accurately and unobtrusively log seizures during activities of daily living would: 1) improve clinical practice by reducing the need for patients to spend time in an Epilepsy Monitoring Unit (EMU) and more quickly identify an appropriate treatment plan; and 2) provide a means to collect real-world data (RWD) for research and clinical purposes. EpiCare@Home is a multimodal device that can continuously record EEG with unobtrusive behind-the-ear electrodes, in addition to cardiorespiratory and physical motion data. The device is intended to be used by a trained healthcare professional (HCP) as a clinical decision support tool during the management of people with epilepsy. The clinical trial aims to analytically validate the performance of the seizure detection component of the device, specifically for focal onset seizures. In addition, it intends to clinically validate the ability of the device to support clinical workflows, from the perspective of healthcare professional and patient users alike.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Two wearable devices (Byteflies Sensor Dots) will be used. One Sensor Dot will be placed in the neck with a skin adhesive and will be connected to EEG electrodes placed behind each ear. The second Sensor Dot will be placed on the chest with an adhesive ECG electrode (i.e., a cardiac "patch").
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Sensitivity of algorithmic detection of potential epileptic events on EpiCare@Home data as compared to video-EEG ground truth annotations.
Analytical validation of the algorithmic processing will be conducted by calculating the sensitivity (recall) of potential epileptic events and comparing it to ground truth annotations. The sensitivity is expected to be 65% or higher.
Time frame: From EMU admission to discharge, up to 10 days
Sensitivity of algorithmic detection of potential epileptic events on a subset of temporal lobe epilepsy EpiCare@Home study participants as compared to video-EEG ground truth annotations.
Analytical validation of the algorithmic processing will be conducted by calculating the sensitivity (recall) of potential epileptic events and comparing it to ground truth annotations. The sensitivity is expected to be 85% or higher.
Time frame: From EMU admission to discharge, up to 10 days
Specificity of the classification of potential epileptic events as seizures by two independent trained reviewers as compared to video-EEG ground truth annotations.
Clinical validation of the ability of trained reviewers to identify "real" seizures will be conducted by calculating the specificity of reviewed events and comparing it to ground truth annotations. The specificity is expected to be 95% or higher.
Time frame: From EMU admission to discharge, up to 10 days
Compare the seizure duration as measured by EpiCare@Home to video-EEG ground truth annotations.
For confirmed seizures in both the EpiCare@Home and ground truth datasets, the length of each event is expected to be 85% similar.
Time frame: From EMU admission to discharge, up to 10 days
Sensitivity and specificity of the potential epileptic events as detected by EpiCare@Home, compared to events recorded in a seizure diary.
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In the optional home portion of the study, participants will be asked to keep a seizure diary. The events recorded in that diary will be compared to validated seizures in the EpiCare@Home dataset to calculate sensitivity and specificity.
Time frame: From EMU discharge until the end of the home use period, for up to 14 days
Post-analysis of the sensitivity of detection of potential epileptic events on subsets of data categorized based on seizure origin.
A post-analysis will be performed to quantify the effect of seizure origin on the sensitivity (recall) of potential epileptic events, as compared to video-EEG ground truth annotations.
Time frame: From EMU admission to discharge, up to 10 days
Interrater reliability (IRR) of the trained reviewers.
The IRR of the trained annotators who conduct clinical validation will be calculated and used to consider if the training was sufficient. A moderate or better reliability (IRR \> 0.60) is expected.
Time frame: From EMU admission to discharge, up to 10 days