04_SERAS_Home_RWD
Research type
Research Study
Full title
Clinical study for the validation of the medical device mjn-SERAS for the detection and prediction of epileptic seizures in individuals from 16 to 65 years, suffering from refractory epilepsy during their day-to-day activity, to find out the impact of the digital solution in a normalised environment and provide valuable real-world data
IRAS ID
323204
Contact name
Arjune Sen
Contact email
Sponsor organisation
MJN Neuro
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, months, days
Research summary
MJN hypothesises that the use of mjn-SERAS device will allow the recording of electroencephalographic activity and subsequent processing of the data by MJN’s artificial intelligence algorithm to anticipate the event of person suffering an epileptic seizure.
Following the launch of an initial study to validate the performance of the MJN artificial intelligence algorithm to detect and predict changes in the EEG graph elements of patients in the Episoft study and the subsequent design and execution of the SERAS-EEG study with the aim of analysing and validating the performance of the mjn-SERAS intra-atrial device versus the "gold-standard" video-EEG (hereinafter v-EEG) as a valid system for the evaluation of the concordance and prediction of the likelihood of epileptic seizures taking place in clinically diagnosed patients, it can be established as a valid preclinical alarm signal against the onset of epileptic seizures. Once the two previous validations, fundamental to establishing the functioning and use of the mjn-SERAS intra-atrial device, have taken place, we now face the greatest challenge of the project: validating the operation of our mjn-SERAS device in day-to-day activities of the patient, i.e., to validate its operation when worn by the patient at home, at school, at work, etc.
We plan prospective analysis of 130 subjects (60 from the UK) with a clinical diagnosis of drug-resistant epilepsy, this will allow the validation of the correlation and operation of the electroencephalographic recording of the mjn-SERAS in the normalised environment of the patient. Also the analysis and reliability of the alert of the possibility of epileptic seizures generated by the mjn-SERAS device to a mobile phone application. The validation of the mjn-SERAS intra-atrial device in a standardised patient environment will provide an objective system for early detection of these comorbid events prior to their clinical manifestation.
REC name
Wales REC 4
REC reference
23/WA/0196
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion