RecruitingOBSERVATIONAL

Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data

This study focuses on a group of brain disorders called Developmental and Epileptic Encephalopathy (DEE). These are complex conditions that affect how the brain develops and can cause seizures. Researchers want to use existing medical information from many patients across the UK to learn more about DEE. By looking at how these conditions progress and identifying specific markers in the body, they hope to better understand the different types of DEE. This knowledge could lead to more tailored treatments for patients, depending on their specific condition. The ultimate goal is to develop better guidelines for doctors on how to manage DEE, which are not currently available.

At a glance

Status

Recruiting

Sponsor

Imagine Institute

Enrolment target

400

Start

31 Oct 2024

Estimated completion

31 Dec 2026

Developmental and Epileptic Encephalopathy

What is this study about?

This study is about a group of conditions called Developmental and Epileptic Encephalopathy, or DEE for short. These are complex brain disorders that often involve both developmental problems and seizures. They can affect people of all ages. Researchers are trying to understand these conditions better, as they can be quite different from one person to another.

To do this, the study isn't actually testing new medicines or treatments. Instead, it's a 'natural history' study. This means the researchers will be looking at existing health information and medical records from many people in the UK who have a diagnosis of DEE. By gathering and analysing this information on a large scale, they hope to get a clearer picture of how DEE develops over time and what might cause it in different people.

The main aim is to find specific clues or 'biomarkers' in the body that can help doctors tell the different types of DEE apart. This will help them understand why these conditions happen and how they progress. Ultimately, this understanding should lead to more personalised care, meaning treatments that are better suited to each individual patient. It could also help create much-needed guidelines for doctors on the best ways to manage DEE.

Key takeaways

This study uses existing medical records, not new treatments.
It aims to understand complex brain conditions called DEE better.
The goal is to find clues that lead to more personalised care.
Participation means your past medical data may be used to help others.
There are no extra appointments or medications involved.
Your privacy is protected, and you can withdraw your consent at any time.

Who may be eligible?

This study is looking for people who have already been diagnosed with Developmental and Epileptic Encephalopathy (DEE).

To be considered, you also need to be registered with or benefit from a social security scheme in the UK. This just means you're part of the UK's social security system, like having an NHS number or receiving certain benefits.

If you or your parents don't want your existing medical information to be used for this study, then you wouldn't be able to take part. Also, if a person is under a legal measure like a guardianship that prevents them from making decisions about their data, they wouldn't be included.

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.

Have you been diagnosed with Developmental and Epileptic Encephalopathy (DEE)?
Are you, or the person whose data would be used, part of the UK's social security system (e.g., have an NHS number)?
Are you (or your parents/legal guardian) comfortable with your existing medical data being used for research?
Are you (or the person whose data would be used) not under any legal order that would prevent data reuse?

Answer every question to see your result.

What does participation involve?

Taking part in this study is different from a typical clinical trial because it doesn't involve any new treatments, medicines, or extra appointments. You won't need to visit a clinic or have any special checks.

Instead, the researchers will be looking at information that's already in your medical records. This means they will be reusing data that your doctors have already collected as part of your usual care. There will be no additional tests or procedures specifically for this study. Your usual care and appointments with your doctors will continue as normal. The study doesn't have a set end date for individual participants, as it's about looking at historical data.

Potential risks and benefits

A potential benefit of taking part is contributing to a better understanding of DEE, which could lead to improved diagnosis and more personalised treatments for patients in the future. While there are no direct medical benefits for individual participants, your data could help many others. For this type of study, because no new treatments are given and only existing data is used, the risks are very low. The main risk is a small chance your personal information could be seen by someone who shouldn't see it, but strict measures are in place to protect your privacy and keep your data safe and anonymous where possible. Remember, you or your child's legal guardian always have the right to decide not to have your data included in the study, and this will not affect your medical care in any way.

Locations (23)

CHU Amiens
Verified postcode
Amiens, France· Not yet recruiting
CH Angers
Verified postcode
Angers, France· Not yet recruiting
Chu Besancon
Verified postcode
Besançon, France· Not yet recruiting
CHU Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
CHRU Brest
Verified postcode
Brest, France· Not yet recruiting
CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
CHU Grenoble
Verified postcode
Grenoble, France· Not yet recruiting
CHU Lille
Verified postcode
Lille, France· Not yet recruiting
CHU Limoges
Verified postcode
Limoges, France· Not yet recruiting
CHU Lyon HCL
Verified postcode
Lyon, France· Not yet recruiting
Assistance Publique Hopitaux de Marseille
Verified postcode
Marseille, France· Not yet recruiting
CHU de Nancy
Verified postcode
Nancy, France· Not yet recruiting

Common questions

What is Developmental and Epileptic Encephalopathy (DEE)?

DEE is a group of complex brain conditions that affect development and often cause seizures.

Do I need to take new medication for this study?

No, this study does not involve any new medications or treatments. It only looks at existing medical information.

Will I have extra doctor's appointments?

No, you won't have any extra appointments. The researchers are using information already collected from your usual care.

How will my personal information be kept safe?

Researchers will follow strict rules to protect your privacy and keep your data secure, often making it anonymous so you can't be identified.

Can I change my mind about being in the study?

Yes, you or your legal guardian can always say you don't want your data used in the study, and it won't affect your medical care.

How to find out more

Rima Nabbout, Pr

rima.nabbout@aphp.fr +33144381536 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.