Department of Clinical Neurophysiology, Danish Epilepsy Centre, Visbys Allé 5, 4293 Dianalund, Denmark.
Department of Clinical Neurophysiology, Danish Epilepsy Centre, Visbys Allé 5, 4293 Dianalund, Denmark; Department of Clinical Neurophysiology, Aarhus University Hospital, and Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 165, 8200 Aarhus, Denmark.
Epilepsy Behav. 2023 Nov;148:109486. doi: 10.1016/j.yebeh.2023.109486. Epub 2023 Oct 17.
The continuously expanding research and development of wearable devices for automated seizure detection in epilepsy uses mostly non-invasive technology. Real-time alarms, triggered by seizure detection devices, are needed for safety and prevention to decrease seizure-related morbidity and mortality, as well as objective quantification of seizure frequency and severity. Our review strives to provide a state-of-the-art on automated seizure detection using non-invasive wearable devices in an ambulatory (home) environment and to highlight the prospects for future research.
A joint working group of the International League Against Epilepsy (ILAE) and the International Federation of Clinical Neurophysiology (IFCN) recently published a clinical practice guideline on automated seizure detection using wearable devices. We updated the systematic literature search for the period since the last search by the joint working group. We selected studies qualifying minimally as phase-2 clinical validation trials, in accordance with standards for testing and validation of seizure detection devices.
High-level evidence (phases 3 and 4) is available only for the detection of tonic-clonic seizures and major motor seizures when using wearable devices based on accelerometry, surface electromyography (EMG), or a multimodal device combining accelerometry and heart rate. The reported sensitivity of these devices is 79.4-96%, with a false alarm rate of 0.20-1.92 per 24 hours (0-0.03 per night). A single phase-3 study validated the detection of absence seizures using a single-channel wearable EEG device. Two phase-4 studies showed overall user satisfaction with wearable seizure detection devices, which helped decrease injuries related to tonic-clonic seizures. Overall satisfaction, perceived sensitivity, and improvement in quality-of-life were significantly higher for validated devices.
Among the vast number of studies published on seizure detection devices, most are strongly affected by potential bias, providing a too-optimistic perspective. By applying the standards for clinical validation studies, potential bias can be reduced, and the quality of a continuously growing number of studies in this field can be assessed and compared. The ILAE-IFCN clinical practice guideline on automated seizure detection using wearable devices recommends using clinically validated wearable devices for automated detection of tonic-clonic seizures when significant safety concerns exist. The studies published after the guideline was issued only provide incremental knowledge and would not change the current recommendations.
可穿戴设备在癫痫中的自动 seizure 检测方面的研究和开发不断扩展，主要使用非侵入性技术。为了安全和预防，需要由 seizure 检测设备触发实时警报，以降低与 seizure 相关的发病率和死亡率，并客观量化 seizure 的频率和严重程度。我们的综述旨在提供使用非侵入性可穿戴设备在非住院（家庭）环境中进行自动 seizure 检测的最新技术，并强调未来研究的前景。
国际抗癫痫联盟（ILAE）和国际临床神经生理学联合会（IFCN）的一个联合工作组最近发布了一份关于使用可穿戴设备进行自动 seizure 检测的临床实践指南。我们根据 seizure 检测设备的测试和验证标准，更新了联合工作组上次搜索以来的系统文献搜索。我们选择了至少符合 2 期临床验证试验标准的研究。
仅基于加速度计、表面肌电图（EMG）或结合加速度计和心率的多模态设备的可穿戴设备检测强直阵挛性 seizure 和主要运动性 seizure 方面，有高级别证据（第 3 阶段和第 4 阶段）。这些设备的报告敏感性为 79.4-96%，假警报率为每 24 小时 0.20-1.92（每夜 0-0.03）。一项单阶段 3 研究验证了使用单通道可穿戴 EEG 设备检测失神性 seizure 的能力。两项 4 期研究表明，用户对可穿戴 seizure 检测设备总体满意，这有助于减少与强直阵挛性 seizure 相关的伤害。验证设备的总体满意度、感知敏感性和生活质量改善均显著更高。
在已发表的大量 seizure 检测设备研究中，大多数研究受到潜在偏倚的严重影响，提供了过于乐观的观点。通过应用临床验证研究标准，可以降低潜在的偏倚，并评估和比较该领域不断增加的研究的质量。关于使用可穿戴设备进行自动 seizure 检测的 ILAE-IFCN 临床实践指南建议，当存在重大安全问题时，使用经临床验证的可穿戴设备进行强直阵挛性 seizure 的自动检测。该指南发布后发表的研究仅提供增量知识，不会改变当前建议。
