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

Recruiting now

Conditions studied: Quality of Life, Epilepsy (treatment Refractory)

In brief

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.

Key facts

Study ID: NCT05845255
Run by: MJN Neuroserveis, S.L
People needed: 130
Starts: 2023-05-01
Expected to finish: 2025-06-30
Last updated by the study team: 2024-10-15

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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).
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.

You may not qualify if…

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 it is running

Clínica Corachan — Barcelona, Barcelona, Spain (enrolling)
CUN — Madrid, Madrid, Spain (enrolling)
Vithas La Milagrosa — Madrid, Madrid, Spain (enrolling)
CUN — Pamplona, Navarre, Spain (enrolling)
Oxford NHS — Oxford, United Kingdom (enrolling)
Diakonie Kork — Kork, Germany

Full record on ClinicalTrials.gov

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