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

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.