Actively Recruiting
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
Led by MJN Neuroserveis, S.L · Updated on 2024-10-15
130
Participants Needed
6
Research Sites
113 weeks
Total Duration
On this page
Sponsors
M
MJN Neuroserveis, S.L
Lead Sponsor
C
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 to 65 years at the time of signing consent
- Confirmed diagnosis of drug-resistant epilepsy with focal, generalized, or focal-generalized seizures
- Epileptic seizures recorded by video-EEG or evaluated by a specialized epilepsy unit
- Clinical history and video-EEG records confirming epilepsy diagnosis
- Detailed semiological information available
- Patients with seizures originating on either side; device placed near focal point
- More than 10 daytime seizures per year and 2 to 4 daytime seizures per month in last 3 months
- Seizures occur during the day, not only at night
- Included in ICD-10 classification as G40 with electroclinical seizure manifestations
- Ability to use or navigate a smartphone with Android or iOS; family assistance allowed if needed
You will not qualify if you...
- Presence of psychogenic non-epileptic seizures that cannot be differentiated from epileptic seizures
- Psychiatric, neurological, or systemic disorders affecting study results
- More than 10 seizures per day regularly
- Presence of epilepsia partialis continua (G40.5)
- Patients represented by a legal guardian
- Pregnant women
- Only absence seizures (G40.A, G40.4)
- Only myoclonic seizures or epileptic spasms (G40.B, G40.4)
- Diagnosed with epileptic syndromes excluded by ICD-10 codes G40.0, G40.4, G40.5, G40.7, G40.9
- Previous participation in clinical trials with the mjn-SERAS device
- Patients not meeting medical criteria for inclusion despite epileptic syndrome classification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Diakonie Kork
Kork, Germany
Active, Not Recruiting
2
Clínica Corachan
Barcelona, Barcelona, Spain
Actively Recruiting
3
CUN
Madrid, Madrid, Spain
Actively Recruiting
4
Vithas La Milagrosa
Madrid, Madrid, Spain
Actively Recruiting
5
CUN
Pamplona, Navarre, Spain
Actively Recruiting
6
Oxford NHS
Oxford, United Kingdom
Actively Recruiting
Research Team
D
David Blánquez, Engineer
CONTACT
F
Fernando Atienza, QM
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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