Currently submitted to: JMIR Preprints
Date Submitted: Mar 24, 2025
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Validation of the mjn-SERAS medical device for the early detection of epileptic seizures in refractory epilepsy patients in a normalised environment: Protocol for a prospective, multicentre, controlled and randomized, pilot clinical study
ABSTRACT
Background:
Approximately one third of epilepsy patients are resistant to anti-seizure medication (ASM). There are currently no mobile devices that allow early detection of seizures. Hypothesized that the use of an intra-aural EEG device (mjn-SERAS) will allow the activity recording and the subsequent processing by the AI algorithm of MJN to anticipate the event of suffering an epileptic seizure in those patients already diagnosed previously, generating an alert to prevent accidents.
Objective:
To assess the epilepsy-related quality of life in patients with drug-resistant epilepsy using the mjn-SERAS solution compared to the control group To assess the seizure-related safety in patients with drug-resistant epilepsy using the mjn-SERAS solution compared to the control group in terms of the number of accidents caused by seizure episodes
Methods:
A prospective, multicentre, pilot clinical trial, with a controlled and randomized design, is proposed to validate a medical device (mjn-SERAS), CE certificated. This new validation will be in the participant's normalized environment, in individuals over 2 years of age, with a diagnosis of refractory epilepsy, which will make it possible to determine the impact of the mjn-SERAS device on the early detection of epileptic seizures and the generation of a pre-seizure alert with a time window of a minimum of 1 minute. The sample size determined is an n=150 exposed individuals who meet the inclusion criteria. The sensitivity, specificity, positive predictive value, PPV and F-Score of the device will be analysed. Also, the degree of satisfaction of patients and their caregivers, including the impact on quality of life and the degree of health perceived by the caregiver when alarms are generated to assess the possibility of a new epileptic seizure. Finally, to describe possible improvements in indicators of social relationships in different areas of personal development.
Results:
This study is funded in 2022 by the EIT Health and European Union, under the programme EIT Health Amplifier n. 220445-230126. As of February 2025, we enrolled 76 patients in 6 clinical sites in Spain, UK and Germany. Data analysis is currently underway, and the first results are expected for June 2025.
Conclusions:
The mjn-SERAS device, an intra-aural EEG, aims to record brain activity and use artificial intelligence (AI) algorithms to anticipate seizures in previously diagnosed patients. By generating early alerts, it allows individuals to take preventive measures and enhance safety. Although participants may not experience direct benefits, validating or improving this technology could enhance future epilepsy management and treatment. Unlike previous research efforts, mjn-SERAS is the first device to systematically provide seizure alerts using an AI-based algorithm to detect early warning signs. Its real-world application could significantly improve the quality of life for epilepsy patients and advance medical understanding of seizure prediction. This study evaluates the device’s accuracy in predicting seizures in everyday settings and assesses its psychological, mental, and social impact on people with refractory epilepsy. Clinical Trial: ClinicalTrials.gov NCT05845255; https://clinicaltrials.gov/study/NCT05845255
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