Validation of the Mjn-SERAS Performance

Study Overview
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Brief Summary
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A prospective, multicentre, postmarketing, pilot 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. The patient's characteristics about epilepsy, drug-resistant epilepsy, inclusion and exclusion criteria for the study. 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 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
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A prospective, multicentre, postmarketing, pilot 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. It is not a controlled and randomised design, 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. 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.

Official Title
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Validation of the Mjn-SERAS Solution for the Detection and Prediction of Epileptic Seizures in Epilepsy Drug-resistant Patients, During Their Day-to-day Activity, to Find Out the Impact in a Normalised Environment.

Conditions
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Performance Enhancing Product Use, Quality of Life

Intervention / Treatment
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* Device: mjn-SERAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical criteria: Confirmed diagnosis of drug-resistant epilepsy, with focal, generalized or focal -generalized seizures, according to international standards from ILAE 2017 classification (link), who will be evaluated by a specialised epilepsy unit and who are expected to have seizures. The video-EEG records of patients must have epileptic seizures counted and recorded by specialised clinical personnel through accepted and contrasted gold-standard systems*3. Patients with a clinical history and previous video-EEG records that allows certainty about the diagnosis and characteristics of the participant's epilepsy. Precise semiological information on the patients included. Patients with both sides localisation will be accepted, and the wearable device will be placed in the side that is most evident the origin of the seizures, to be placed as near as possible to the focal point. Presence of more than 10 seizures per year, from tonic, tonic-clonic, clonic or atonic seizures, reported by the patients/caregivers or assessed by the neurologist through the patient history. Patients included in ICD-10 classification as G40 (link) with electroclinical manifestation of seizures ▪ Technological criteria: Ability to navigate in Android operating system. Patients with lack of Android mobile phone will be provided with device and/or training as appropriate. Exclusion Criteria: Presence of psychogenic seizures. Psychiatric, neurological, or systemic disorders that the researcher believes could affect the realisation and interpretation of the results. Presence of more than 10 seizures per day on a habitual basis. Presence of epilepsia partialis continua Patients with legal representative Patients with only absence seizures, myoclonic seizures or epileptic spasms. Patients included in ICD-10 classification G40.0 Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset G40.4 Other generalized epilepsy and epileptic syndromes G40.5 Special epileptic syndromes G40.9 Epilepsy, unspecified

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: mjn-SERAS|Using of wearable, non-invasive device for EEG recording and forecasting of epileptic seizures|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life index of patients with epilepsy | 1. To assess the quality of life of patients with epilepsy and the degree of health perceived by the patient and caregiver when using the mjn-SERAS solution to generate alarms when the possibility of a new epileptic seizure is anticipated. Endpoint : o Change in the epilepsy-related quality of life (QOLIE-31) after the use of the mjn-SERAS solution at T3 period, end of T2 period, 6 months minimum. Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) o QOLIE-31, Quality of Life Index Epilepsy | 12 months | 
| Change in quality of life 5D of patients with epilepsy | 1. To assess the quality of life of patients with epilepsy and the degree of health perceived by the patient and caregiver when using the mjn-SERAS solution to generate alarms when the possibility of a new epileptic seizure is anticipated. Endpoints : o Change in the health-related quality of life (EQ-5D-5L) after the use of the mjn-SERAS solution at T3 period, end of T2 period, 6 months minimum. Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) o EQ-5D-5L | 12 months | 
| Patient's safety | 2. To assess the evolution of the patient's safety related with accidents in patients with epilepsy when using the mjn-SERAS solution. Endpoint o Change in the number of accidents caused by seizures episodes during the use of the mjn-SERAS solution in the T2 period, 6 months minimum, assessed in T3 period. Evaluation Creating a baseline data by bibliography and comparing with the results after the study, making a specific questionnaire and evaluating it for each patient. This questionnaire will include questions about burns, head injuries, dental injuries, bone fractures or other fractures as a result of a seizure. They will be asked also about the consequences of those injuries. Initial assessment refers to previous 6 months before the device and post-assessment will be refer to the time the participant has been participating in the T2 period (Pre-Post assessment, baseline vs T3 period) | 12 months | 
| Change in mental and emotional well-being | 3. To analyse the change in the mental and emotional well-being of patients with epilepsy who regularly use the mjn-SERAS solution. Endpoints : Change in emotional well-being and quality of life (SCL-90-R Anxiety dimension) of the patient after the use of the mjn-SERAS, at T3 period, end of T2 period, 6 months minimum. Change in emotional well-being and quality of life (SCL-90-R Depression dimension) of the patient after the use of the mjn-SERAS, at T3 period, end of T2 period, 6 months minimum. Change in emotional well-being and quality of life (SCL-90-R Hostility dimension) of the patient after the use of the mjn-SERAS, at T3 period, end of T2 period, 6 months minimum. Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) Questionnaire SCL-90-R Anxiety dimension. Questionnaire SCL-90-R Depression dimension. Questionnaire SCL-90-R Hostility dimension. | 12 months | 
| Change in quality of life social relationships | 4. To analyse the evolution of social relationships indicators in different areas of personal development in patients with epilepsy who regularly use the MJN SERAS solution. Endpoints : o Change in social relationships dimension (QOLIE-31) of the patient after the use of the mjn-SERAS, at T3 period, end of T2 period, 6 months minimum Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) o Social relationships dimension in QOLIE-31. | 12 months | 
| Change in social relationships and physical functioning | 4. To analyse the evolution of social relationships indicators in different areas of personal development in patients with epilepsy who regularly use the MJN SERAS solution. Endpoints : o Change in physical functioning dimension (SF-36) of the patient after the use of the mjn-SERAS, at T3 period, end of T2 period, 6 months minimum Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) o Physical functioning dimension in SF-36. | 12 months | 
| Change in social relationships and role limitations | 4. To analyse the evolution of social relationships indicators in different areas of personal development in patients with epilepsy who regularly use the MJN SERAS solution. Endpoints : o Change in role limitations due to physical health (SF-36) and autonomy of the patient after the use of the mjn-SERAS, at T3 period, end of T2 period, 6 months minimum. Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) o Role limitations due to physical health in SF-36. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health resources utilization | 5. Assess the impact on health care resources utilization (including associated sick leave) as a result of the ability to take preventive measures ahead of a seizure. Endpoint : o Change in use of healthcare resources, variation in frequency of use of resources, for mjn-SERAS solution, at T3 period, end of T2 period, 6 months minimum. Evaluation : Healthcare resources*1 related to seizures during at least 2 months before and after starting to use the mjn-SERAS will be collected. Days of sick leave due to seizures (only in patients actively employed) and hours per week needing a caregiver (informal care) in each period will also be collected. Healthcare resources*1: Health care resources related to seizures are number of visits to general practitioner, specialists and emergency room, hospitalizations, outpatient procedures, hours of formal care and unscheduled visits or any other use of resources. | 12 months | 
| Seizure correlation for patients report | 6a. Measure the correlation between the warning alarms of mjn-SERAS solution and the report provided by the patient/caregiver/families regarding the presence of clinically significant epileptic seizures, as well as to analyse the algorithm for evaluating the possibility of seizure presentation and its subsequent correlation and agreement with the clinical phase. Endpoints : Correlation of seizures with patient report and the reliability of mjn-SERAS reports for the coordination of treatment processes with healthcare providers at T3 period, end of T2 period, 6 months minimum. Evaluation : The report provided by patients/caregiver is assumed as the criterion for the presence of seizures, validated by a double check, automatic seizure detection soft, automatic review, and neurologist review, human review. | 12 months | 
| Seizure correlation for patient knowledge | 6b. Measure the correlation between the warning alarms of mjn-SERAS solution and the report provided by the patient/caregiver/families, as well as to analyse the algorithm for evaluating the possibility of seizure presentation and its subsequent correlation and agreement with the clinical phase. Endpoints : o Change in the communication between patients and healthcare providers, and the coordination of treatment processes, adapting the therapy to the real needs of the patient, with a Patient Knowledge questionnaire, at T3 period, end of T2 period, 6 months minimum. Evaluation : Creation of a baseline in the Patient knowledge questionnaire (link) with questions to doctors and KOL(Key Opinion Leaders), asking for the expectations about the use of similar solutions and performing a post-assessment with the clinical professionals involved in the study about the accomplishment of these expectations. (Pre-Post assessment) | 12 months | 
| Medical device performance | 7. To analyse and validate the mjn-SERAS solution in the standard patient environment as a system for assessing the possibility of epileptic seizures, generating an alarm prior to the clinical evidence or manifestation of a seizure to avoid accidents*2 Endpoint : o mjn-SERAS medical device performance*3 at the end of T2 period, 6 months minimum. Evaluation : percentage rates of the digital solution Sensitivity (rate of assessment of positive seizure possibilities with a positive clinical episode) Specificity (rate of assessment of a negative seizure possibility with a negative clinical episode) Accuracy (positive predictive value, PPV) F-Score (weighted average of accuracy, accuracy, considering the imbalance of cases) Medical device performance*3: Performance of a clinical function, other than that related to basic safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk. | 12 months | 
| Device safety evaluation with questionnaire | 8. To analyse the usability and device-related safety of the digital solution in normal life conditions, normalised environment, with a daily use by the patient. Endpoint : Device safety evaluation, at T3 period, end of T2 period, 6 months minimum. Evaluation : Study questionnaire, Device dimension (Post assessment) (Questionnaires definition link) | 12 months | 
| Device safety evaluation and adverse effects | 8. To analyse the usability and device-related safety of the digital solution in normal life conditions, normalised environment, with a daily use by the patient. Endpoint : Device safety evaluation, at T3 period, end of T2 period, 6 months minimum. Evaluation : Adverse effects notification, Clinical Investigational Report (CIR) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety and Performance, Medical device, Quality of life