Halford Jonathan J, Sperling Michael R, Nair Dileep R, Dlugos Dennis J, Tatum William O, Harvey Jay, French Jacqueline A, Pollard John R, Faught Edward, Noe Katherine H, Henry Thomas R, Jetter Gina M, Lie Octavian V, Morgan Lola C, Girouard Michael R, Cardenas Damon P, Whitmire Luke E, Cavazos Jose E
Department of Neurology, Medical University of South Carolina, Charleston, South Carolina, U.S.A.
Department of Neurology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, U.S.A.
Epilepsia. 2017 Nov;58(11):1861-1869. doi: 10.1111/epi.13897. Epub 2017 Oct 5.
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).
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.
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.
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.
开展一项前瞻性多中心III期试验，以评估用于检测全身强直阵挛性发作（GTCS）的可穿戴式表面肌电图（sEMG）监测系统在癫痫监测单元（EMU）中的性能和耐受性。
199例有GTCS病史的患者入住11个IV级癫痫中心的EMU进行临床指征的视频脑电图监测，同时使用一种可穿戴设备在肱二头肌上方的手臂上进行sEMG监测。所有记录的sEMG数据均在中心站点使用先前开发的检测算法进行处理。将检测到的GTCS与由三位专家评审员中的多数人验证的事件进行比较。
对于所有受试者，检测算法检测到46次GTCS中的35次（76%，95%置信区间[CI]=0.61-0.87），阳性预测值（PPV）为0.03，平均误报率（FAR）为每24小时2.52次。对于将设备放置在肱二头肌中线处记录的数据，系统检测到29次GTCS中的29次（100%，95%CI=0.88-1.00），检测延迟平均为7.70秒，PPV为6.2%，平均FAR为每24小时1.44次。28%（199例中的55例）的受试者报告了轻度至中度不良事件，9%（199例中的17例）的受试者因此退出研究。这些不良事件主要由电极贴片引起的皮肤刺激组成，未经治疗即可缓解。未报告严重不良事件。
使用肱二头肌上的sEMG监测设备检测GTCS是可行的。该设备的正确放置对于准确性很重要，对于一些患者来说，尽量减少假阳性的数量可能具有挑战性。
