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

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: MJN Neuroserveis, S.L · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A prospective, multicentre, postmarketing, with a controlled and randomized design, 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. 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. A control group will be randomized to assess the difference between both groups. 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. From a methodological point of view, the general clinical variables to be included are the number of seizures (determining the onset of the seizure according to medical criteria), the type of seizure, semiological characteristics, duration, identification of the lateralisation of the epileptic focus, type of epilepsy, aetiology and pharmacological resistance. The patient will also be asked to report all the alarms and seizures using a simple app on his/her mobile phone in order to subsequently analyse and determine the results according to the patient's own experience. Chronologically the study will be split in 3 phases and 4 periods: * Phase 1, Baseline * T0 period, 2 months after recruiting for baseline creation, questionnaires, and quality of life. * Phase 2, Intervention * T1 period, 4 to 10 weeks minimum, for artificial intelligence algorithm training with real seizures from the patients. * T2 period, 6 months minimum, for run-time algorithm, seizure risk alert mode. * Phase 3, Results * T3 period for closing and comparing with baseline, questionnaires, and quality of life. The improvement in quality of life will be assessed in a Randomized Control Trial design plus a pre-post assessment, comparing the initial questionnaires from T0 period with the ending questionnaires from T3 period. There will be several questionnaires, epilepsy specific questionnaire for Quality of Life as QOLIE-31, and generic as EQ-5D-5L. Also, questionnaires as HADS, SCL-90-R and PAM-13 will be performed for anxiety, depression, hostility, physical functioning and role limitations dimension. The digital solution is composed by a software application in the mobile phone and a recording wearable. The application is based on artificial intelligence algorithms to generate the alerts and warning for the patient, receiving a visual, vibration and sound alert when the level is reaching the high risk, allowing the patient to take personal safety measures, that are not included in the protocol. The main functionalities are the warning system, the calendar of seizures and the information for the patient. The main functionalities of mjn-SERAS solution are applied to improve the quality of life of patients and improve their safety regarding epilepsy seizures. Receiving seizure alerts before they happen implies a great advantage for these patients, since the main problem with epileptic seizures is the uncertainty of when the next seizure will be, which generates a state of anxiety and constant vigilance, both for the patients and for their relatives. Receiving an alert, a notice, before the seizure will allow them to be safe and avoid accidents and injuries caused by the seizure, which will still happen, but with less impact on the person. Just being able to reduce the state of anxiety of the person represents a very considerable improvement in the quality of life, medical benefit, since the stress indices will drop, and the person's safety will rise. Therefore, we can allow the person to carry out certain activities that until now were limited, such as walks, shopping, better schooling, social activities, so that their autonomy is greatly increased. This increase in autonomy is closely related to the possibility of avoiding accidents and injuries caused by seizures, so that by suffering the seizure in a more controlled environment we can avoid many negative consequences and increase the patient safety. Avoiding accidents, improving the quality of life and improving social relationships makes the person have an improvement in their state of health, since they will have fewer injuries and fewer side effects due to these seizures. The patient will have a digital diary of the seizures to report date and time of the seizure, as well as other information, intensity of the seizure(duration) and accidents caused by the seizure. The reports may include both real seizures and those detected by the patients, as well as two other types: psychogenic seizures that patients suffer but do not have an electrical manifestation on the EEG and, on the other hand, subclinical seizures, with an electrical manifestation on the EEG but without clinical manifestation in the patient. All these data will be extracted from the application in an easy way, with a friendly interface according to specific guidelines, with a printable form and human-readable information. It is a pdf document that the patient can easily download and share with medical professionals. The Epilepsy management service, is an educational feature that will help patients in their day-to-day life, it is composed by useful information containing for each country and language: * Information about the disease * Classification of seizures * Epilepsy treatments and medications * What to do in a seizure * Links of interest * Patients' associations in their country * Regional societies of epilepsy * Clinical centers * Useful information in videos It is a dynamic information based on a webview connection in the application, where information is updated periodically and with the possibility of adding features online without necessity of update in the patient application.

Conditions

• Quality of Life
• Epilepsy (treatment Refractory)

Interventions

Type	Name	Description
DEVICE	mjn-SERAS	Using of wearable, non-invasive device for EEG recording and forecasting of epileptic seizures

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-30
• Completion: 2025-06-30
• First posted: 2023-05-06
• Last updated: 2024-10-15

Locations

6 sites across 3 countries: Germany, Spain, United Kingdom