Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System

What this Trial Is About

Researchers are evaluating a new wearable device called the Ear-Seizure Detection Device (EarSD) designed to detect and predict epileptic seizures. This study aims to validate how accurately the EarSD device records seizures compared to the standard video-electroencephalogram (video-EEG) monitoring used in the Epilepsy Monitoring Unit (EMU). The goal is also to see if the device offers more comfort, is less intrusive during daily activities, and provides additional insights into seizure control for patients with epilepsy. Participants admitted to the EMU who are undergoing continuous video 21-electrode EEG and electrocardiogram (ECG) monitoring will wear the EarSD device simultaneously. The EarSD is an ear-worn device that records multiple signals including EEG, electromyogram, electrooculogram, photoplethysmogram, electrodermoactivity, and inertial motion data. There is no randomization; all enrolled patients will use the device during their EMU stay. Daily skin checks and electrode replacements will be done as needed, and the device will be removed at the end of the study period. During the study, participants will be monitored for an average of 7 days while wearing the EarSD and undergoing standard video-EEG monitoring. Researchers will assess seizure detection accuracy and prediction capabilities over a longer term, up to 5 years, and analyze data interpretation for up to 2 years. Participants will also complete a short survey about their experience wearing the device. Safety monitoring includes daily skin assessments to check for irritation, ensuring participant comfort throughout the study.

Ear-Seizure Detection (EarSD) Study