Danish Epilepsy Center, member of the European Reference Network EpiCARE, Dianalund, Denmark.
University of Copenhagen, Copenhagen, Denmark.
Epilepsia. 2024 Nov;65(11):3265-3278. doi: 10.1111/epi.18121. Epub 2024 Sep 28.
This study was undertaken to assess the clinical utility, safety, and tolerability in epilepsy patients of ultra long-term monitoring with a novel subcutaneous electroencephalographic (EEG) device (sqEEG).
Five patients with drug-resistant focal epilepsy were implanted (one patient bilaterally) with sqEEG. In phase 1, we assessed sqEEG sensitivity for seizure recording by recording seizures simultaneously with scalp EEG in the epilepsy monitoring unit (EMU). sqEEG was scored either visually (v-sqEEG) or by using a semiautomatic algorithm (EpiSight; E-sqEEG). In phase 2, the patients were monitored as outpatients for 3-6 months. sqEEG data were analyzed monthly, evaluating concordance of data obtained by v-sqEEG, E-sqEEG, and patients' diaries. v-sqEEG data were used to guide treatment adjustments. sqEEG-related side effects were assessed throughout the study.
In phase 1, v-sqEEG detected all seizures recorded in the EMU in all patients, whereas E-sqEEG was as effective in three patients. In the other two patients, E-sqEEG detected only a proportion or none of the seizures, respectively. Sensitivity of E-sqEEG depended on the ictal EEG features. In phase 2, a 100% concordance between E-sqEEG and v-sqEEG in seizure detection was observed for the same three patients as in phase 1. In the other two patients (one implanted bilaterally), effectiveness of E-sqEEG in detecting seizure as compared to v-sqEEG ranged from 0% to 83%. v-sqEEG showed that all patients reported in their diaries fewer seizures than they actually suffered. In four of five patients, v-sqEEG showed that the treatment adjustments had been ineffective or associated with a seizure increment. The only side effect was an infection at the implantation site in one patient.
The sqEEG system could collect reliable information on seizure activity, thus providing clinically relevant information. Sensitivity of EpiSight in detecting seizures varied across patients, depending on the ictal EEG features. sqEEG ultra long-term monitoring was feasible and well tolerated.
本研究旨在评估新型皮下脑电图（EEG）设备（sqEEG）在癫痫患者中的超长期监测的临床实用性、安全性和耐受性。
5 例耐药性局灶性癫痫患者植入（1 例双侧）sqEEG。在第 1 阶段，我们通过在癫痫监测单元（EMU）中同时记录头皮 EEG 来评估 sqEEG 对癫痫记录的敏感性。sqEEG 通过视觉（v-sqEEG）或半自动算法（EpiSight；E-sqEEG）进行评分。在第 2 阶段，患者作为门诊患者进行 3-6 个月的监测。每月分析 sqEEG 数据，评估 v-sqEEG、E-sqEEG 和患者日记获得的数据的一致性。根据 v-sqEEG 数据调整治疗方案。整个研究过程中评估了与 sqEEG 相关的副作用。
在第 1 阶段，v-sqEEG 在所有患者中均检测到 EMU 中记录的所有癫痫发作，而 E-sqEEG 在 3 例患者中同样有效。在另外两名患者中，E-sqEEG 分别仅检测到部分或没有癫痫发作。E-sqEEG 的敏感性取决于发作期 EEG 特征。在第 2 阶段，在第 1 阶段相同的 3 名患者中，E-sqEEG 和 v-sqEEG 在癫痫发作检测方面的一致性达到 100%。在另外两名患者（双侧植入）中，E-sqEEG 检测癫痫发作的有效性与 v-sqEEG 相比，范围从 0%到 83%。v-sqEEG 显示所有患者在日记中报告的癫痫发作次数少于实际发作次数。在 5 名患者中的 4 名中，v-sqEEG 显示治疗调整无效或与癫痫发作增加有关。唯一的副作用是 1 名患者的植入部位感染。
sqEEG 系统可以收集可靠的癫痫活动信息，从而提供有临床意义的信息。EpiSight 在检测癫痫发作方面的敏感性因患者而异，取决于发作期 EEG 特征。sqEEG 超长期监测是可行的，并且耐受性良好。
