From the Department of Clinical Neurophysiology (S.B.), Danish Epilepsy Centre Dianalund and Aarhus University Hospital; FORCE Technology (I.C.), Hørsholm, Denmark; Department of Clinical Neurophysiology (O.H.), National Centre for Epilepsy, Oslo University Hospital, Norway; Department of Clinical Neurophysiology (M.F.), Copenhagen University Hospital Rigshospitalet; Department of Neurology (P.W.), Danish Epilepsy Centre, Dianalund, Denmark; and Postgraduate Programme in Clinical Medicine (P.W.), Federal University of Santa Catarina, Florianópolis, Brazil.
Neurology. 2018 Jan 30;90(5):e428-e434. doi: 10.1212/WNL.0000000000004893. Epub 2018 Jan 5.
To determine the accuracy of automated detection of generalized tonic-clonic seizures (GTCS) using a wearable surface EMG device.
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.
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.
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.
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).
确定使用可穿戴表面肌电图设备自动检测全面性强直-阵挛发作(GTCS)的准确性。
我们前瞻性测试了使用可穿戴表面肌电图设备实时检测发作的技术性能和诊断准确性。预设了发作检测算法和截断值。共有 71 名患者因怀疑 GTCS 而被转诊至 3 个中心进行长期视频-脑电图监测。发作检测是实时和完全自动化的。参考标准是由经过培训的专家对视频-脑电图记录的评估,他们对设备数据一无所知。对设备中的发作记录进行解读是盲法的,不了解其他所有数据。
每位患者的平均记录时间为 53.18 小时。总记录时间为 3735.5 小时,设备缺陷时间为 193 小时(设备开启时间的 4.9%)。未发生不良事件。可穿戴设备的灵敏度为 93.8%(32 次 GTCS 中有 30 次被检测到)。中位发作检测潜伏期为 9 秒(范围为-4 至 48 秒)。假警报率为 0.67/d。
可穿戴肌电图设备的性能满足了患者的需求:它以超过 90%的灵敏度和 30 秒内的检测潜伏期检测到 GTCS。
这项研究提供了 II 级证据,表明对于有 GTCS 病史的患者,可穿戴肌电图设备能准确检测到 GTCS(灵敏度为 93.8%,假警报率为 0.67/d)。