Ultra long-term EEG monitoring for developmental and epileptic encephalopathies: protocol for a prospective study using subscalp EEG

IF 2 Q3 NEUROSCIENCES

Clinical Neurophysiology Practice Pub Date : 2026-01-01 Epub Date: 2025-12-20 DOI:10.1016/j.cnp.2025.12.005

Leonardo Affronte , Stefania Maffei , Mara Malerba , Giada Giovannini , Paolo Manganotti , Antonietta Coppola , Leonilda Bilo , Anna Elisabetta Vaudano , Marina Trivisano , Nicola Specchio , Stefano Meletti

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引用次数: 0

Abstract

Objective

Poor documentation of seizures can be a major challenge in epilepsy. Objective seizure counting with mobile devices might improve this challenge and the patient management. We investigate whether ultra long-term subcutaneous EEG improves seizure documentation and disease monitoring in adults and adolescents with developmental and epileptic encephalopathies (DEEs).

Methods

Ultra long-term subcutaneous EEG Monitoring In Rare Epilepsies and DEE (EMIRE) is a multi-centre prospective interventional study with an expected duration of 6 months. 33 Adolescents and adult participants will be implanted with 24/7 EEG SubQ and collect 2-channel EEG data up to 6 months. Data will be reviewed by experts on a weekly basis and a summary sent to the treating clinician.

Results

(1) safety and tolerability of subcutaneous EEG in this special patient population; (2) seizure detection sensitivity and specificity with respect to patients’ seizure-diaries and ‘ground truth’; (3) whether and how home monitoring can affect the clinical management of the patients.

Conclusions

This project will investigate home and remote patient monitoring systems, offering an accuracy that is unthinkable today.

Significance

This trial of home monitoring is intended to be of clinical utility to the patient by allowing objective assessment of therapeutic interventions and their effectiveness.

Plain language summary.

We present a clinical trial protocol for a prospective cohort study in people with severe epilepsies across Italy. The study aims to assess whether an EEG implant placed under the skin (1) is more accurate than patient-reported seizure diary, (2) is feasible and acceptable to patients and clinicians, (3) affect the clinical management of the patients, (4) reduces the impact of epilepsy.

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发育性和癫痫性脑病的超长期脑电图监测：一项使用头皮下脑电图的前瞻性研究方案

目的癫痫发作的不良记录可能是癫痫的主要挑战。目的：利用移动设备进行癫痫发作计数可以改善这一挑战和患者管理。我们研究超长时间皮下脑电图是否能改善成人和青少年发育性和癫痫性脑病（dee）的癫痫发作记录和疾病监测。方法超长时间皮下脑电图监测在罕见癫痫和DEE （EMIRE）是一项多中心前瞻性介入研究，预计持续时间6个月。33名青少年和成人参与者将被植入24/7 EEG SubQ，并收集长达6个月的双通道EEG数据。数据将由专家每周审查一次，并将总结发送给治疗临床医生。结果(1)皮下脑电图在这一特殊患者群体中的安全性和耐受性；(2)癫痫发作检测的敏感性和特异性相对于患者的癫痫发作日记和“基础真相”；(3)家庭监护是否以及如何影响患者的临床管理。该项目将调查家庭和远程患者监测系统，提供当今难以想象的准确性。这项家庭监测试验旨在通过客观评估治疗干预措施及其有效性，为患者提供临床应用。简单的语言总结。我们提出了一项意大利严重癫痫患者前瞻性队列研究的临床试验方案。该研究旨在评估皮下植入脑电图（EEG）是否(1)比患者报告的癫痫日记更准确，(2)对患者和临床医生来说是否可行和可接受，(3)影响患者的临床管理，(4)减少癫痫的影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Neurophysiology Practice NEUROSCIENCES-

CiteScore

3.90

自引率

0.00%

发文量

审稿时长

71 days

期刊介绍： Clinical Neurophysiology Practice (CNP) is a new Open Access journal that focuses on clinical practice issues in clinical neurophysiology including relevant new research, case reports or clinical series, normal values and didactic reviews. It is an official journal of the International Federation of Clinical Neurophysiology and complements Clinical Neurophysiology which focuses on innovative research in the specialty. It has a role in supporting established clinical practice, and an educational role for trainees, technicians and practitioners.