Evaluating a device for improving quality of life in epilepsy patients

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.

This study is testing a new device that helps people with drug-resistant epilepsy by detecting seizures early and sending alerts to see if it can improve their quality of life.

Quick facts

• Study type: Observational
• Enrollment: 130 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: MJN Neuroserveis, S.L (Industry-sponsored)
• Locations: 6 sites (Kork and 5 other locations)
• Trial ID: NCT05845255 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate the mjn-SERAS medical device in real-world settings for patients with drug-resistant epilepsy. It will involve 130 subjects aged 12 to 65 years across multiple centers in Spain, Germany, and the UK. The study focuses on assessing the device's effectiveness in early seizure detection and generating pre-seizure alerts, thereby potentially improving the quality of life for participants. The study will adhere to international standards for epilepsy classification and will be conducted in participants' normalized environments.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 12 to 65 with a confirmed diagnosis of drug-resistant epilepsy.

Not a fit: Patients who do not have drug-resistant epilepsy or are outside the age range of 12 to 65 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance the quality of life for patients with drug-resistant epilepsy by providing timely alerts for seizure occurrences.

How similar studies have performed: Other studies have shown promise in using similar devices for seizure detection, but this specific validation in real-world settings is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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).

  o In case of epileptic syndromes not listed in the above or shows some of the syndromes mentioned in the exclusion criteria, patients could be included according to medical criteria defined by the clinician. These criteria must be accordingly justified by the clinician ( e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording).
* 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.

Exclusion criteria

* 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.)
* 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).
* Patients included in ICD-10\*4 and ICD-10-GM\*5 classification and not included in the medical criteria for specific epileptic syndromes in inclusion criteria.

  * 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
  * G40.9 Epilepsy, unspecified
* Participants in previous clinical trials with mjn-SERAS device.
* In the case the patient presents an epileptic syndrome mentioned in the exclusion criteria, the patient if the clinician considers the subject meets medical criteria to be included, the patient can be enrolled in the study. These criteria must be accordingly justified by the clinician (e.g., focal or generalized onset seizures without encephalopathy and with a normal interictal EEG recording

Where this trial is running

Kork and 5 other locations

• 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)

Study contacts

• Principal investigator: Antonio Gil-Nagel, MD PhD — Department of Neuroscience Clinica Corachan & Synaptia Health Projects
• Study coordinator: David Blánquez, Engineer

Conditions Quality of Life; Epilepsy; Safety and Performance; Medical device; Quality of life