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 focal -generalized seizures, according to international standards from ILAE 2017 classification*2 (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 or evaluated by a specialized epilepsy unit and expected to experience seizures with electroclinical manifestations If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.
Patients with a clinical history and previous video-EEG records that allows certainty about the diagnosis and characteristics of the participant's epilepsy. If there are clear clinical epileptic seizures (e.g. motor seizures), patients could be involved even without v-EEG records, according to medical criteria.
Precise semiological information on the patients included.
Ability to navigate in Android or iOS operating system. If mild or moderate disability, family members can assist with navigation if patient is unable. The smartphone must stays with the patient to record EEG, but seizures are registered by a family member.
Presence of psychogenic seizures.
If there is a coexistence of epileptic and non-epileptic seizures, it will be considered an exclusion criterion if the patient or family cannot differentiate between the two types of seizures.
If the patient or family can always differentiate between the two types of seizures, the patient could be included in the study according to medical criteria (but only recording the epileptic seizures.)
According to the 2005 World Health Organization (WHO) report, epilepsy is a disease that affects about 1% of the population worldwide. 30% of patients are resistant to antiepileptic treatment. It is proposed a clinical trial for people from 12 to 65 years, in a day-to-day activity outside hospital. It will be a prospective 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 of this study.
Case-control
Prospective
mjn-SERAS
DeviceUsing of wearable, non-invasive device for EEG recording and forecasting of epileptic seizures
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 when using the mjn-SERAS solution to generate alarms when the possibility of a new epileptic seizure is anticipated. • Endpoint : Change from baseline in the epilepsy-related quality of life (QOLIE-31 questionnaire for adults 18 to 65 and QOLIE-AD-48 questionnaire for adolescents 12 to 17) after the use of the mjn-SERAS solution during T2 period, assessed in T3 period and including pre-post assessment and comparison between intervention and control group. • Evaluation : Questionnaires answered by patients (Pre-Post assessment, baseline vs T3 period) QOLIE-31, Quality of Life Index Epilepsy and QOLIE-AD-48
Patient's safety associated with seizure-related accidents
2\. To assess the evolution of the patient's safety related with seizure-related accidents in patients with epilepsy when using the mjn-SERAS solution. * Endpoint Change from baseline in the number of seizure-related accidents and injuries during the use of the mjn-SERAS solution in the T2 period, assessed in T3 period, including pre-post assessment and comparison between intervention and control group. * Evaluation Evaluation will be performed at the T3 period with a comparison of number and severity of accidents between control group, as baseline, and intervention group, using the device.
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.
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.
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
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.
Specification of patients for the use of mjn-SERAS solution
9\. The creation of a database that allows the relation of semiological variables, location of the epileptic focus and the specific results of the mjn-SERAS solution in each of the cases. * Endpoint : * Specification of patients for the use of the mjn-SERAS solution * Measurement : * Segmentation of the cases through artificial intelligence using as features the EEG parameters and the clinical variables
Specification of seizures for AI(Artificial Intelligence) algorithm
10\. To analyse the results of the mjn-SERAS solution according to the different crisis semiology. * Endpoint : * Specification of seizures for artificial intelligence algorithm * Measurement : Segmentation of different semiologies to compare the ratios * TPR(sensitivity, True Positive Rate) * TNR(specificity, True Negative Rate) * PPV(Positive Prediction Value) * FAR(False Alarm Rate)
Knowledge dissemination to doctors
11\. To increase the knowledge of healthcare professionals on the patient and the disease, by way of accessing EEG records and seizures to make better decisions on treatment and therapies . * Endpoint : * Knowledge dissemination to doctors and scientific community * Evaluation : * Creation of a baseline with questions to physicians about patient knowledge in seizures and medication, as well as performing a post-assessment with the clinical professionals involved in the study. (Pre-Post assessment)
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.
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MJN Neuroserveis, S.L
Lead sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborator
Oxford University Hospitals NHS Trust
Collaborator
Diakonie Kork
Collaborator
Clínica Corachan
Collaborator
