Viana Pedro F, Duun-Henriksen Jonas, Biondi Andrea, Winston Joel S, Freestone Dean R, Schulze-Bonhage Andreas, Brinkmann Benjamin H, Richardson Mark P
Institute of Psychiatry, Psychology and Neuroscience, King's College London, London SE5 9RT, United Kingdom.
Epilepsy Centre, King's College Hospital NHS Foundation Trust, London SE5 9RS, United Kingdom.
medRxiv. 2024 Nov 18:2024.11.16.24317163. doi: 10.1101/2024.11.16.24317163.
Novel subcutaneous electroencephalography (sqEEG) systems enable prolonged, near-continuous cerebral monitoring in real-world conditions. Nevertheless, the feasibility, acceptability and overall clinical utility of these systems remains unclear. We report on the longest observational study using ultra long-term sqEEG to date.
We conducted a 15-month prospective, observational study including ten adult people with treatment-resistant epilepsy. After device implantation, patients were asked to record sqEEG, to use an electronic seizure diary and to complete acceptability and usability questionnaires. sqEEG seizures were annotated visually, aided by automated detection. Seizure clustering was assessed via Fano Factor analysis and seizure periodicity at multiple timescales was investigated through circular statistics.
Over a median duration of 438 days, ten patients recorded a median 18.8 hours/day, totalling 71,984 hours of real-world sqEEG data. Adherence and acceptability remained high throughout the study. While 754 sqEEG seizures were recorded across patients, over half (52%) of these were not reported in the patient diary. Of the 140 (27%) diary reports not associated with an identifiable sqEEG seizure, the majority (68%) were reported as seizures with preserved awareness. The sqEEG to diary F1 agreement score was highly variable, ranging from 0.06 to 0.97. Patient-specific patterns of seizure clustering and seizure periodicity were observed at multiple (circadian and multidien) timescales.
We demonstrate feasibility and high acceptability of ultra long-term (months-years) sqEEG monitoring. These systems help provide real-world, more objective seizure counting compared to patient diaries. It is possible to monitor individual temporal fluctuations of seizure occurrence, including seizure cycles.
新型皮下脑电图（sqEEG）系统能够在现实环境中进行长时间、近乎连续的大脑监测。然而，这些系统的可行性、可接受性和整体临床实用性仍不明确。我们报告了迄今为止使用超长期sqEEG进行的最长观察性研究。
我们进行了一项为期15个月的前瞻性观察性研究，纳入了10名成年难治性癫痫患者。在植入设备后，要求患者记录sqEEG，使用电子癫痫日记，并完成可接受性和可用性问卷。sqEEG癫痫发作通过自动检测辅助进行视觉标注。通过法诺因子分析评估癫痫发作聚类，并通过循环统计研究多个时间尺度上的癫痫发作周期性。
在中位时长438天的时间里，10名患者中位每天记录18.8小时，共产生71984小时的现实世界sqEEG数据。在整个研究过程中，依从性和可接受性一直很高。虽然患者共记录到754次sqEEG癫痫发作，但其中超过一半（52%）未在患者日记中报告。在140次（27%）与可识别的sqEEG癫痫发作无关的日记报告中，大多数（68%）被报告为意识保留的癫痫发作。sqEEG与日记的F1一致性评分变化很大，范围从0.06到0.97。在多个（昼夜和多天）时间尺度上观察到了患者特异性的癫痫发作聚类和癫痫发作周期性模式。
我们证明了超长期（数月至数年）sqEEG监测的可行性和高可接受性。与患者日记相比，这些系统有助于提供现实世界中更客观的癫痫发作计数。有可能监测癫痫发作发生的个体时间波动，包括癫痫发作周期。
