Detection of generalized tonic-clonic seizures using surface electromyographic monitoring.

OBJECTIVE: A prospective multicenter phase III trial was undertaken to evaluate the performance and tolerability in the epilepsy monitoring unit (EMU) of an investigational wearable surface electromyographic (sEMG) monitoring system for the detection of generalized tonic-clonic seizures (GTCSs). METHODS: One hundred ninety-nine patients with a history of GTCSs who were admitted to the EMU in 11 level IV epilepsy centers for clinically indicated video-electroencephalographic monitoring also received sEMG monitoring with a wearable device that was worn on the arm over the biceps muscle. All recorded sEMG data were processed at a central site using a previously developed detection algorithm. Detected GTCSs were compared to events verified by a majority of three expert reviewers. RESULTS: For all subjects, the detection algorithm detected 35 of 46 (76%, 95% confidence interval [CI] = 0.61-0.87) of the GTCSs, with a positive predictive value (PPV) of 0.03 and a mean false alarm rate (FAR) of 2.52 per 24 h. For data recorded while the device was placed over the midline of the biceps muscle, the system detected 29 of 29 GTCSs (100%, 95% CI = 0.88-1.00), with a detection delay averaging 7.70 s, a PPV of 6.2%, and a mean FAR of 1.44 per 24 h. Mild to moderate adverse events were reported in 28% (55 of 199) of subjects and led to study withdrawal in 9% (17 of 199). These adverse events consisted mostly of skin irritation caused by the electrode patch that resolved without treatment. No serious adverse events were reported. SIGNIFICANCE: Detection of GTCSs using an sEMG monitoring device on the biceps is feasible. Proper positioning of this device is important for accuracy, and for some patients, minimizing the number of false positives may be challenging.

Automated Processing of Single-Channel Surface Electromyography From Generalized Tonic-Clonic Seizures to Inform Semiology.

PURPOSE: Advances in surface electromyography (sEMG) monitoring allow for long-term data collection in a natural environment, giving objective information that may identify risk of sudden unexpected death in epilepsy and guide clinical decision-making. Generalized tonic-clonic seizure semiology, namely motor tonic and clonic phase duration, may be an important factor in determining the level of seizure control and risk of sudden unexpected death in epilepsy. This study demonstrates a quantitative analysis of sEMG collected with a dedicated wearable device. METHODS: During routine monitoring, 23 generalized tonic-clonic seizures from 19 subjects were simultaneously recorded with video-EEG and sEMG. A continuous wavelet-transform was used to determine the frequency components of sEMG recorded during generalized tonic-clonic seizures. An automated process, incorporating a variant of cross-validation, was created to identify ideal frequencies and magnitude ranges for tonic and clonic phases and determine phase durations. Phase durations determined using sEMG analysis were compared with phase durations determined by independent epileptologists' review of video-EEG. RESULTS: Cross-validation revealed that the optimal frequency bands for tonic and clonic phases are 150 to 270 Hz and 12 to 70 Hz, respectively. The average difference in phase duration calculated using the two methods for tonic and clonic phases and total seizure duration were -0.42 ± 4.94, -5.12 ± 9.68, and -5.11 ± 11.33 seconds, respectively (results presented are TsEMG - TvEEG, µ ± σ). CONCLUSIONS: The automated processing of sEMG presented here accurately identified durations of tonic, clonic, and total motor durations of generalized tonic-clonic seizures similar to durations identified by epileptologists' review of video-EEG.