To determine the accuracy of automated detection of generalized tonic-clonic seizures (GTCS) using a wearable surface EMG device.Methods
We prospectively tested the technical performance and diagnostic accuracy of real-time seizure detection using a wearable surface EMG device. The seizure detection algorithm and the cutoff values were prespecified. A total of 71 patients, referred to long-term video-EEG monitoring, on suspicion of GTCS, were recruited in 3 centers. Seizure detection was real-time and fully automated. The reference standard was the evaluation of video-EEG recordings by trained experts, who were blinded to data from the device. Reading the seizure logs from the device was done blinded to all other data.Results
The mean recording time per patient was 53.18 hours. Total recording time was 3735.5 hours, and device deficiency time was 193 hours (4.9% of the total time the device was turned on). No adverse events occurred. The sensitivity of the wearable device was 93.8% (30 out of 32 GTCS were detected). Median seizure detection latency was 9 seconds (range −4 to 48 seconds). False alarm rate was 0.67/d.Conclusions
The performance of the wearable EMG device fulfilled the requirements of patients: it detected GTCS with a sensitivity exceeding 90% and detection latency within 30 seconds.Classification of evidence
This study provides Class II evidence that for people with a history of GTCS, a wearable EMG device accurately detects GTCS (sensitivity 93.8%, false alarm rate 0.67/d).