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.

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Diakonie Kork
ACTIVE_NOT_RECRUITING
Kork
Spain
Clínica Corachan
RECRUITING
Barcelona
CUN
RECRUITING
Madrid
Vithas La Milagrosa
RECRUITING
Madrid
CUN
RECRUITING
Pamplona
United Kingdom
Oxford NHS
RECRUITING
Oxford
Contact Information
Primary
David Blánquez, Engineer
david@mjn.cat
+34652918809
Backup
Fernando Atienza, QM
fatienza@mjn.cat
+34 645 86 25 25
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 130
Related Therapeutic Areas
Sponsors
Collaborators: Clinica Universidad de Navarra, Universidad de Navarra, Diakonie Kork, Clínica Corachan, Oxford University Hospitals NHS Trust
Leads: MJN Neuroserveis, S.L

This content was sourced from clinicaltrials.gov