Summary
Objective
Our primary goal was to measure the accuracy of fully automated absence seizure detection, using a wearable EEG device. As a secondary goal, we also tested the feasibility of automated behavioral testing triggered by the automated detection.
Methods
We conducted a phase-3 clinical trial (NCT04615442), with a prospective, multicenter, blinded study design. The input was the one-channel EEG recorded with dry electrodes embedded into a wearable headband device connected to a smartphone. The seizure detection algorithm was developed using artificial intelligence (convolutional neural networks). During the study, the pre-defined algorithm, with pre-defined cut-off value, analyzed the EEG in real-time. The gold standard was derived from expert evaluation of simultaneously recorded full-array video-EEGs. In addition, we evaluated the patients´ responsiveness to the automated alarms on the smartphone, and we compared it with the behavioral changes observed in the clinical video-EEGs.
Results
We recorded 102 consecutive patients (57 female; median age: 10 years) on suspicion of absence seizures. We recorded 364 absence seizures in 39 patients. Device deficiency was 4.67%, with a total recording time of 309 hours. Average sensitivity per patient was 78.83% (95%CI: 69.56-88.11%) and median sensitivity was 92.90% (IQR: 66.7-100%). The average false detection rate was 0.53/h (95%CI: 0.32-0.74). Most patients (n=66; 64.71%) did not have any false alarms. The median F1 score per patient was 0.823 (IQR: 0.57-1). For the total recording duration, F1 score was 0.74. We assessed the feasibility of automated behavioral testing in 36 seizures: it documented correctly non-responsiveness in 30 absence seizures, and responsiveness in six electrographic seizures.
Significance
Automated detection of absence seizures with a wearable device will improve seizure quantification and will promote assessment of patients in their home environment. Linking automated seizure detection to automated behavioral testing will provide valuable information from wearable devices.
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