OBJECTIVE: 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).