Condition: Quality of Life · Epilepsy (treatment Refractory) · Sponsor: MJN Neuroserveis, S.L
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.
This description comes directly from the study's public registry record.
David Blánquez, Engineer · +34652918809 · david@mjn.cat
Fernando Atienza, QM · +34 645 86 25 25 · fatienza@mjn.cat
Always discuss trial participation with your own doctor first.
| Diakonie Kork | Kork, Germany | Active Not Recruiting |
| Clínica Corachan | Barcelona, Barcelona, Spain | Recruiting |
| CUN | Madrid, Madrid, Spain | Recruiting |
| Vithas La Milagrosa | Madrid, Madrid, Spain | Recruiting |
| CUN | Pamplona, Navarre, Spain | Recruiting |
| Oxford NHS | Oxford, United Kingdom | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05845255