RecruitingPHASE3INTERVENTIONAL

In Vivo Involvement of the Cholinergic and Dopaminergic Systems in the Pathophysiology of Apathy.

This study aims to understand why some people experience 'apathy' – a strong lack of motivation – after a stroke. Apathy can make life difficult for both patients and their families. Researchers believe it might be linked to how certain brain chemicals, called dopamine and acetylcholine, are working. Using advanced brain scans called PET and MRI, they will look at these chemical systems in patients who have had a stroke, comparing those with apathy to those without it. The main goal is to find out if there are specific changes in these brain chemicals that contribute to apathy. This knowledge could help doctors develop more effective treatments and support for people struggling with motivation after a stroke, ultimately improving their quality of life.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

13 Apr 2021

Estimated completion

13 May 2027

Apathy

What is this study about?

Apathy is when someone has a noticeable lack of interest or motivation to do things, even everyday tasks. This isn't just feeling a bit down; it's a significant change in a person's drive that can make life much harder for them and their loved ones. It can happen after a stroke and is different from depression, although it might look similar on the surface. We don't fully understand why apathy happens, which makes it tricky for doctors to treat effectively.

This study wants to explore how two important chemical messengers in the brain, called dopamine and acetylcholine, might be involved. These chemicals help control things like movement, motivation, and learning. Researchers will use special scanning techniques, like PET scans, to get a detailed picture of how these chemicals are working in the brains of people who've had a stroke. By comparing people who have apathy with those who don't, they hope to pinpoint specific differences.

They will also use MRI scans, which provide detailed images of the brain's structure, to get an even clearer picture. Combining these different types of scans will help the research team understand which parts of the brain are affected and how these chemical messengers play a role. Ultimately, this research aims to provide a much better understanding of apathy, which could lead to better ways of identifying and treating it in the future, helping more people regain their motivation and improve their quality of life after a stroke.

Key takeaways

This study investigates apathy after a stroke.
It uses special brain scans (PET and MRI) to look at brain chemicals.
The goal is to better understand apathy and find potential treatments.
Participation involves scans and questionnaires, but no new medicines.
Your involvement could help improve future care for stroke patients.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would generally need to be an adult between 18 and 75 years old who has experienced a stroke. You might or might not be experiencing apathy, as both groups are needed for comparison. You should also be able to move around fairly well after your stroke and not have severe brain damage shown on scans.

There are also some reasons why you might not be able to join. For example, if you are taking certain medications that affect brain chemicals like dopamine or acetylcholine (such as some antidepressants or medicines for allergies), you probably wouldn't be able to participate. Also, if you have other serious health conditions like severe heart failure, certain chronic neurological problems, or significant memory issues, the study might not be suitable for you.

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 18 and 75 years old?
Have you had a stroke and are able to move around fairly well now?
Are you NOT taking medications like certain antidepressants or strong allergy medicines?
Do you NOT have severe heart problems or other serious brain conditions?
Are you NOT pregnant or breastfeeding?
Are you able to attend a few hospital visits for scans and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several assessments. This includes special brain scans called PET scans, which involve receiving a tiny, safe amount of a special substance to help researchers see how your brain chemicals are working. You will have two of these PET scans to look at different chemicals, and you will also have an MRI scan, which creates detailed pictures of your brain using magnets and radio waves.

You will also complete some questionnaires and tests to assess your mood, thinking skills, and levels of apathy. The study is designed to involve a couple of follow-up visits after the initial assessments. The total duration of your participation will include these visits over several months. You won't be given any new medication as part of this study; it focuses on understanding your brain's current state.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gained could help many others in the future by improving our understanding and treatment of apathy after a stroke. Like all medical procedures, the scans carry a small risk; for example, PET scans involve a very small amount of radiation, similar to naturally occurring background radiation, and MRI scans can be noisy and feel confined. You will receive detailed information about all potential risks before you decide to join. Remember, taking part in any research study is completely voluntary, and you are free to withdraw at any time without giving a reason, and it will not affect your medical care.

Locations (1)

Bordeaux University Hospital
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is apathy in this study?

Apathy means having a significant lack of motivation or interest in activities, even after a stroke, and it's being studied here to understand its brain connections.

What are PET and MRI scans?

PET and MRI are types of brain scans. PET scans look at chemical activity in the brain, while MRI scans give detailed pictures of the brain's structure.

Will I receive new medication?

No, this study is observational. You will not be given any new medication as part of taking part.

Is there any radiation involved?

Yes, PET scans use a tiny, safe amount of radiation, similar to what you might naturally encounter in daily life.

Can I leave the study at any time?

Absolutely. Your participation is voluntary, and you can withdraw from the study at any point without it affecting your medical care.

How to find out more

Nicolas BALAMOUTOFF

nicolas.balamoutoff@chu-bordeaux.fr 05 56 79 55 40 Official trial record

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