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
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.
Confirmed diagnosis of drug-resistant*1 epilepsy, with focal, generalized or foc... [+11]
Ability to navigate in Android or iOS operating system. If mild or moderate disa... [+18]