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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

NCT05845255 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Quality of Life
  • Epilepsy (treatment Refractory)

Interventions

DEVICE

mjn-SERAS

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

Sponsors & Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra

    collaborator OTHER

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • Diakonie Kork

    collaborator UNKNOWN

  • Clínica Corachan

    collaborator UNKNOWN

  • MJN Neuroserveis, S.L

    lead INDUSTRY

Principal Investigators

  • Antonio Gil-Nagel, MD PhD · Department of Neuroscience Clinica Corachan & Synaptia Health Projects

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-12-30
Completion
2025-06-30

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845255 on ClinicalTrials.gov