Validation of the Mjn-SERAS Performance

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Performance Enhancing Product Use
• Intervention / Treatment: Device: mjn-SERAS

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: David Blánquez, Engineer; Phone Number: +34652918809; Email: david@mjn.cat
• Study Contact Backup: Name: Fernando Atienza, QM; Phone Number: +34 645 86 25 25; Email: fatienza@mjn.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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.; Endpointo 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.; EvaluationCreating 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 solutionSensitivity (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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
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 ratiosTPR(sensitivity, True Positive Rate)TNR(specificity, True Negative Rate)PPV(Positive Prediction Value)FAR(False Alarm Rate)	12 months
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)	12 months
Knowledge dissemination to scientific community	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 :Reports and publications	12 months

Collaborators and Investigators

• Sponsor: MJN Neuroserveis, S.L
• Collaborators: Clinica Universidad de Navarra, Universidad de Navarra; Oxford University Hospitals NHS Trust; Diakonie Kork; Clínica Corachan
• Investigators: Principal Investigator: Antonio Gil-Nagel, MD PhD, Department of Neuroscience Clinica Corachan & Synaptia Health Projects

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Medical device; Safety and Performance
• Other Study ID Numbers: 04_SERAS_Home_RWD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No