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 | Recruiting

• 1 other identifier: 04_SERAS_Home_RWD
• Study Type: observational
• Target: 130
• Locations: 3 countries
• Sites: 6

Brief 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)

Keywords

Safety and Performance; Medical device; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• 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.

  6 months

Secondary Outcomes (9)

• Change in health resources utilization

  12 months

• Seizure correlation for patients report

  12 months

• Change in quality of life 5D of patients with epilepsy

  6 months

• Change in social relationships and role limitations

  12 months

• Change in mental and emotional well-being

  12 months

Other Outcomes (6)

• Specification of patients for the use of mjn-SERAS solution

  12 months

• Specification of seizures for AI(Artificial Intelligence) algorithm

  12 months

• Knowledge dissemination to doctors

  12 months

Interventions

mjn-SERAS DEVICE

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

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age criterion:
• o Patient must be 12 to 65 years of age inclusive, at the time of signing the informed consent.
• Clinical criteria:
• 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.
• 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 day seizures per year, from tonic, tonic-clonic, clonic or atonic seizures, and a minimum of 2 to 4 day seizures per month (preferably 4 per month/ 1 per week) during the last 3 months, reported by the patients/caregivers or assessed by the neurologist through the patient history. The patient must have seizures during the day to record them, not just seizures at night.
• Patients included in ICD-10\*4 and ICD-10-GM\*5 classification as G40 with electroclinical manifestation of seizures.
• G40.1 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple focal seizures
• G40.2 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex focal seizures
• G40.3 Generalized idiopathic epilepsy and epileptic syndromes
• G40.6 Grand mal seizures, unspecified (with or without petit mal). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).
• G40.8 Other epilepsies (Epilepsies and epileptic syndromes, undetermined whether focal or generalized). According to medical criteria and electroclinical seizure manifestations (focal, focal-generalized or generalized onset seizure with a normal interictal EEG recording).

You may not qualify if:

• Technological criteria:
• 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 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.)
• 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 (G40.5\*4\*5)
• Patients with legal representative
• Pregnant women
• Patients with only absence seizures (G40.A\*4,G40.4\*5)
• Patients with only myoclonic seizures or epileptic spasms (G40.B\*4,G40.4\*5).
• G40.0 Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
• G40.4 Other generalized epilepsy and epileptic syndromes. In case of specific epileptic syndromes, patients could be included according to medical criteria (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording)
• G40.5 Epileptic seizures due to external causes\*4 or Special epileptic syndromes\*5
• G40.7 Petit mal, unspecified, without grand mal seizures

Sponsors & Collaborators

• MJN Neuroserveis, S.L: lead
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Diakonie Kork: collaborator
• Clínica Corachan: collaborator

Study Sites (6)

Diakonie Kork

Kork, Germany

ACTIVE NOT RECRUITING

Clínica Corachan

Barcelona, Barcelona, Spain

RECRUITING

CUN

Madrid, Madrid, Spain

RECRUITING

Vithas La Milagrosa

Madrid, Madrid, Spain

RECRUITING

CUN

Pamplona, Navarre, Spain

RECRUITING

Oxford NHS

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Antonio Gil-Nagel, MD PhD

  Department of Neuroscience Clinica Corachan & Synaptia Health Projects

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Blánquez, Engineer

CONTACT

+34652918809; david@mjn.cat

Fernando Atienza, QM

CONTACT

+34 645 86 25 25; fatienza@mjn.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: May 6, 2023
• Study Start: May 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

DE (1); ES (4); GB (1)