Real world testing and cost-effectiveness analysis of subcutaneous EEG (REAL-ASE): Protocol for a prospective...

Epilepsy is a common condition associated with significant morbidity, mortality, and costs. Poor documentation of seizures is a major challenge in epilepsy care. Objective seizure counting with mobile devices may mitigate this challenge and improve patient management. The aim of this study is to investigate whether ultra long-term subcutaneous EEG improves seizure documentation and disease monitoring in people with drug-resistant epilepsy.

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE) is a UK-based multi-centre prospective interventional study with an expected duration of 7 months. Thirty-three adult participants will be implanted with 24/7 EEG SubQ and collect 2-channel EEG data for 6 months. Data will be reviewed and annotated by experts, and a summary sent to the treating clinician weekly. The treating clinician will communicate information from this annotation report to participants monthly. Changes in management can be made at the treating clinician's discretion. REAL-ASE was approved by the Bromley Research Ethics Committee in July 2023 (reference number 23/LO/0419).

We anticipate that subcutaneous EEG may improve seizure documentation and be a well-accepted addition to epilepsy care by clinicians and patients. We believe it will be associated with better quality of life and will be a cost-effective solution.

If our study demonstrates improved seizure documentation with subcutaneous EEG, this may contribute to patient safety, improved quality of life, and a reduction in healthcare costs.

We present a clinical trial protocol for a prospective cohort study of 33 people with epilepsy across the UK. 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) reduces the impact of epilepsy, and (4) is beneficial to the National Health Service (NHS).