Validation of the Mjn-SERAS Performance

Quality of Life Clinical Trial

Official title: Validation of the Mjn-SERAS Solution for the Detection and Prediction of Epileptic Seizures in Epilepsy Drug-resistant Patients, During Their Day-to-day Activity, to Find Out the Impact in a Normalised Environment.

Status Not yet recruiting

Clinical Trial Summary

A prospective, multicentre, postmarketing, pilot clinical study is proposed to validate in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe. The patient's characteristics about epilepsy, drug-resistant epilepsy, inclusion and exclusion criteria for the study. This new validation will take place in the participant's normalised environment, in individuals between 12 and 65 years of age, of both sexes with a diagnosis of drug-resistant epilepsy to determine the impact of the mjn-SERAS 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.

Clinical Trial Description

A prospective, multicentre, postmarketing, pilot clinical study is proposed to validate in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe by BSI(British Standard Institution) Group (CE2797) notified body CE 685187. The study will be performed in Spain, Germany and UK (United Kingdom). The patient's characteristics about epilepsy, drug-resistant epilepsy, inclusion and exclusion criteria for the study, considering the same classification in ICD-10 (International Statistical Classification of Diseases) for Spain and NHS(National Health Services) in the UK, and ICD(International Classification of Diseases) ICD-10-GM for Germany, and the target population where the researchers will study the solution are the same for the 3 countries, so all are considering the international standards from ILAE(International League Against Epilepsy) 2017 classification, including German Society for Epileptology and ILAE British Chapter, defined in next sections. This new validation will take place in the participant's normalised environment, in individuals between 12 and 65 years of age, of both sexes with a diagnosis of drug-resistant epilepsy, according to CE mark considerations and intended use, which will make it possible to determine the impact of the mjn-SERAS 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 sensitivity, specificity and accuracy of the medical device solution in the studied environment will also be calculated. The pre-determined sample size determined is an n=130 exposed individuals who meet the inclusion criteria. The patients will be recruited in Spain, Germany, and UK. It is not a controlled and randomised design, the pre-post assessment for each patient will allow to compare data before and after the use of the mjn-SERAS solution, creating a baseline initially and a final evaluation. The method applied during the study consists of using a mjn-SERAS, software application with the earpiece of the external auditory canal customised for the patient. ;

Related Conditions & MeSH terms

• Performance Enhancing Product Use
• Quality of Life

• NCT number: NCT05845255
• Study type: Observational
• Source: MJN Neuroserveis, S.L
• Contact: David Blánquez, Engineer
• Phone: +34652918809
• Email: david@mjn.cat
• Status: Not yet recruiting
• Start date: May 1, 2023
• Completion date: December 30, 2024