Evidence map›Paper›PMID 40492935›Full record

ArticleEpilepsia open2025

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

Matthew McWilliam, Pedro F Viana, Eren Dursun, Joe Davies, Joel S Winston, Jessica Agren, Harutomo Hasegawa, Jonas Duun-Henriksen, Mark P Richardson

Abstract read
In one paragraph

Article in Epilepsia open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Matthew McWilliamInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.ORCID https://orcid.org/0009-0009-4325-3941
Pedro F VianaInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.ORCID https://orcid.org/0000-0003-0861-8705
Eren DursunInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Joe DaviesInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.ORCID https://orcid.org/0009-0005-2229-6732
Joel S WinstonInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.ORCID https://orcid.org/0000-0002-3957-0612
Jessica AgrenUNEEG Medical A/S, Lillerød, Denmark.
Harutomo HasegawaEpilepsy Centre, King's College Hospital NHS Foundation Trust, London, UK.
Jonas Duun-HenriksenUNEEG Medical A/S, Lillerød, Denmark.ORCID https://orcid.org/0000-0003-1558-8225
Mark P RichardsonInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Funding

National Institute for Health and Care Research NIHR 203420
6 · The paper itself

Abstract

objectiveEpilepsy 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.

methodsReal 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).

resultsWe 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. SIGNIFICANCE: 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. PLAIN LANGUAGE SUMMARY: 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).

Indexed as

EEGelectroencephalographyepilepsymobile technologyseizureswearables

Identifiers

PMID40492935
PMCPMC13394026

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.