AuthorisedTherapeutic exploratory (Phase II)Interventional

Impact of epilepsy on the brainstem adenosine pathway and its relation with arousal and respiratory reactivity BRAVE

This research is investigating how epilepsy might affect an important part of the brain called the brainstem, specifically a pathway involving a chemical called adenosine. The brainstem is crucial for controlling your breathing and how awake you feel. The study aims to compare how this adenosine pathway functions in people who have epilepsy that hasn't been controlled well by medication, against healthy volunteers. They'll be looking at brain activity when participants breathe in air with a little more carbon dioxide than usual. The hope is to better understand how epilepsy impacts these vital brain functions, which could eventually lead to improved care for people living with the condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hospices Civils De Lyon

Enrolment target

Start

30 Apr 2026

Neurology

What is this study about?

This research, called BRAVE, is designed to understand a little more about how epilepsy affects the brain. Specifically, it focuses on a part of the brain called the brainstem, which is really important for things we do without thinking, like breathing and staying awake. The study is looking at a particular chemical pathway in this area, involving something called adenosine. Researchers want to see if this pathway works differently in people with epilepsy that hasn't responded well to standard medicines, compared to healthy individuals.

The main goal is to measure the activity of this adenosine pathway in the brainstem when people breathe in air that has slightly more carbon dioxide in it. This helps researchers understand how the brain's breathing control system responds. They're also looking at other brain areas, like the outer layers (cortex), and how quickly people respond to changes in breathing. By comparing people with epilepsy to healthy volunteers, the study hopes to find out if there are specific differences in brain function that could explain some common challenges faced by people with epilepsy.

Ultimately, understanding these pathways better could be a vital step. If researchers can pinpoint exactly how epilepsy changes these crucial brain functions, it might open doors to developing new ways to help people living with epilepsy in the future, particularly concerning breathing control and alertness.

Key takeaways

Targets brainstem adenosine pathways in epilepsy.
Compares drug-resistant epilepsy patients to healthy individuals.
Uses special brain scans (PET and MRI).
Focuses on breathing control and arousal.
Aims to improve understanding of epilepsy's impact.
Does not involve new medication for participants.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can potentially take part.

Both men and women are welcome to participate in this study. The researchers are looking for a diverse group of people to ensure the findings are as broad as possible.

Crucially, the study is comparing people who have epilepsy that hasn't been fully controlled by medication with healthy volunteers. Specific medical criteria will be checked by the research team to make sure you fit the study's requirements.

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 18 years old or older?
Do you have epilepsy that hasn't been fully controlled by medication (if applicable)?
Are you comfortable with undergoing brain scans?
Are you male or female and willing to participate?
Are you able to attend multiple study visits?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll undergo some specialised brain scans, including one called a PET scan, which helps measure the adenosine pathway activity, and an MRI scan to look at brain structure. During these scans, you might be asked to breathe in air with a slightly higher level of carbon dioxide, which is a normal, safe process controlled by the research team.

You will also have other assessments to measure your general health, breathing responses, and daily caffeine intake. The study is designed to involve several visits over a period, but the exact number and duration of these visits will be explained in detail by the research team. You won't be given any new medication as part of this study, as it's observational.

Potential risks and benefits

Taking part in research always has a balance of potential benefits and risks. You might not directly benefit from taking part, but your contribution could help doctors and scientists understand epilepsy better, potentially leading to improved care for others in the future. Risks might include discomfort during scans, or exposure to a small amount of radiation from the PET scan, similar to a few months of natural background radiation. All procedures are carefully monitored by medical professionals. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is the brainstem and why is it important?

The brainstem is a vital part of your brain that controls basic functions like breathing, heart rate, and staying awake. This study looks at how epilepsy might affect it.

What does 'drug-resistant epilepsy' mean?

This refers to epilepsy that hasn't been well controlled by seizure medications. The study is comparing people with this type of epilepsy to healthy individuals.

Will I have to take any new medicine for this study?

No, this study does not involve taking any new medications. It's focused on understanding how your brain works using scans and observations.

What is 'hypercapnic condition'?

This means breathing in air with a slightly higher level of carbon dioxide than usual. It's a safe way for researchers to see how your body responds to changes in breathing.

How long will the study participation last?

The study involves a series of visits, and the research team will explain the full schedule and overall duration of your participation if you are interested.