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
This research study is looking at how a medical device called mjn-SERAS affects the lives of people with epilepsy. This device aims to detect epileptic seizures early and provide a pre-seizure alert at least a minute before it happens. The study involves 130 participants aged 12 to 65 in the UK, Spain, and Germany who have epilepsy that is difficult to control with standard medication. Researchers want to see if using mjn-SERAS in daily life improves their quality of life, helps prevent seizure-related accidents, and how accurate the alerts are. The device is already certified in Europe, and this study will provide more real-world information on its benefits and how well it works.
At a glance
What is this study about?
This study is a research project designed to look at a new medical device called mjn-SERAS. This device is specifically for people who live with epilepsy that hasn't improved much with standard medications. The main goal is to understand if using mjn-SERAS in day-to-day life can improve a person's quality of life and help prevent accidents linked to seizures. The device aims to detect seizures early and give a warning before they start, ideally at least one minute beforehand.
The mjn-SERAS device has already been approved in Europe, which means it meets certain safety and performance standards. This particular study is about gathering more information on how well it works and its impact when used by people in their usual home environment, rather than in a clinic. Researchers will also be checking how accurate the device is at spotting seizures and giving warnings.
The study involves 130 people in total, taking place in the UK, Spain, and Germany. Participants will use the device in their normal lives, and researchers will compare how they are doing before and after using mjn-SERAS. This will help them understand the real-world benefits of the device for people living with epilepsy.
Key takeaways
- New device (mjn-SERAS) being studied for epilepsy.
- Aims to detect seizures early and give warnings.
- For people aged 12-65 with hard-to-treat epilepsy.
- Looking at impact on quality of life and seizure-related accidents.
- Study involves using the device at home.
- Device already approved in Europe; this study gathers real-world data.
Who may be eligible?
To join this study, participants need to be between 12 and 65 years old. You must have a confirmed diagnosis of epilepsy that hasn't responded well to medication. This means your seizures continue even with treatment. Your epilepsy should involve seizures that affect the body's movements, such as tonic, tonic-clonic, clonic, or atonic seizures.
Researchers will need to confirm your epilepsy diagnosis and seizure types based on your medical history, possibly including past video EEG recordings. You should also be experiencing at least 10 seizures per year that happen during the day, with ideally 4 seizures happening each month over the last three months.
It's important that you have seizures that happen during the day, as the device is designed to detect these. Your medical team will help decide if this study is suitable for you based on all these criteria.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 12 and 65 years old?
- Has your epilepsy not responded well to medication?
- Do you experience at least 10 daytime seizures per year?
- Do you have a confirmed diagnosis of epilepsy?
- Are your seizures mainly those affecting body movements (e.g., tonic, clonic)?
- Have you had at least 2-4 daytime seizures per month recently?
What does participation involve?
If you take part in this study, you will be using the mjn-SERAS device in your everyday life. Before you start using the device, researchers will gather some information about your health and how your epilepsy affects you. This will create a 'starting point' to compare against later.
You will then use the mjn-SERAS device as part of your daily routine. Throughout the study, there will be assessments to see how you are doing, how the device is working, and if it's impacting your quality of life. The study will look at your experience before you started using the device and after. The total duration of your participation will be explained by the study team.
Potential risks and benefits
Locations (6)
- Diakonie KorkVerified postcodeKork, Germany· Active not recruiting
- Clínica CorachanVerified postcodeBarcelona, Spain· Recruiting
- CUNVerified postcodeMadrid, Spain· Recruiting
- Vithas La MilagrosaVerified postcodeMadrid, Spain· Recruiting
- CUNVerified postcodePamplona, Spain· Recruiting
- Oxford NHSVerified postcodeOxford, United Kingdom· Recruiting
Common questions
What is mjn-SERAS?
It's a medical device designed to detect epileptic seizures early and provide a warning before they happen.
Who can take part in this study?
People aged 12 to 65 with epilepsy that hasn't responded well to medication, and who experience daytime seizures.
Where is this study happening?
The study is taking place in the UK, Spain, and Germany.
What will I have to do if I join?
You will use the mjn-SERAS device in your normal daily life, and researchers will collect information about your health and seizures before and after using it.
Has this device been tested before?
Yes, mjn-SERAS has already been approved and certified for use in Europe.
How to find out more
David Blánquez, Engineer
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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