超長期脳波モニタリングによる発達性・てんかん性脳症の評価：皮下脳波を用いた前向き研究プロトコル

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).

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.

(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.

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

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.