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RECRUITING
NCT05845255

Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data

Sponsor: MJN Neuroserveis, S.L

View on ClinicalTrials.gov

Summary

The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology of their epilepsy is considered to be of interest for the validation in the day-to-day life a medical device (mjn-SERAS), which has already been validated and certified in Europe with CE mark Class IIa. 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 in quality of life 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.

Official title: Clinical Study for the Validation of the Medical Device Mjn-SERAS for the Detection and Prediction of Epileptic Seizures in Individuals from 12 to 65 Years, Suffering from Drug-resistant Epilepsy During Their Day-to-day Activity, to Find Out the Impact of the Digital Solution in the Quality of Life in a Normalised Environment and Provide Valuable Information from Real-World Data.

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2023-05-01

Completion Date

2025-06-30

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DEVICE

mjn-SERAS

Using of wearable, non-invasive device for EEG recording and forecasting of epileptic seizures

Locations (6)

Diakonie Kork

Kork, Germany

Clínica Corachan

Barcelona, Barcelona, Spain

CUN

Madrid, Madrid, Spain

Vithas La Milagrosa

Madrid, Madrid, Spain

CUN

Pamplona, Navarre, Spain

Oxford NHS

Oxford, United Kingdom