Active not recruitingOBSERVATIONAL

Glymphatic MRI in Clinically Isolated Syndrome

This research investigates how a natural brain cleaning system, called the glymphatic system, works in people who have Clinically Isolated Syndrome (CIS). CIS is often the first sign of Multiple Sclerosis (MS). The brain has a system to remove waste, and if it doesn't work well, these waste products can build up, causing swelling and damage to brain cells. This happens in diseases like Parkinson's and Alzheimer's, and doctors suspect it might also be a problem in MS. We're using a special type of MRI scan, a new technique, to look for changes in this cleaning system in people with CIS. The study hopes to show whether problems with this system play a role in developing MS, potentially linking it to symptoms or signs of brain cell damage. If this pilot study is successful, it could lead to bigger studies to understand MS better.

At a glance

Status

Active not recruiting

Sponsor

University of Exeter

Enrolment target

Start

01 May 2024

Estimated completion

31 Dec 2026

Clinically Isolated Syndrome

What is this study about?

Imagine your brain has its own built-in cleaning crew, called the 'glymphatic system'. This system helps to wash away waste products that build up in your brain. When this cleaning crew isn't working as well as it should, these waste products can start to pile up. This build-up can lead to swelling and damage to brain cells, which we see in some brain diseases like Parkinson's or Alzheimer's.

Now, there's another condition called Multiple Sclerosis (MS), where the body's immune system mistakenly attacks the brain and spinal cord. Doctors believe that problems with this brain cleaning system might also play a part in MS. This study is specially looking at people with Clinically Isolated Syndrome (CIS). CIS is often the very first sign that someone might develop MS, so understanding what happens at this early stage is really important.

Researchers have developed a clever new way to use a type of brain scan called an MRI to see if this cleaning system is working properly. By using this new scan in people with CIS, the study hopes to discover if a faulty glymphatic system is linked to the first signs of MS, new symptoms, or changes in the blood that show brain cells are being damaged. If we find this link, it could open the door to new ways of understanding and potentially helping people with MS in the future.

Key takeaways

This study uses a non-invasive MRI scan.
It aims to understand a brain 'cleaning system' in early MS.
Participation involves two visits, including an MRI and blood tests.
Results could help improve understanding of MS.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you need to be at least 18 years old, male or female, and healthy enough to take part in all the assessments, as decided by the study doctor. You must also understand and be happy to follow all the study steps, which will be fully explained to you before you agree to take part.

If you have Clinically Isolated Syndrome (CIS) or had MS diagnosed for the first time, you might be eligible. However, you can't have been given certain medications like steroids or plasma exchange in the month before you agree to join. You'll also need good eyesight and hearing for the tests. If you are a woman who could become pregnant, you must be using a reliable form of birth control.

However, you won't be able to join if you have a clear diagnosis of Multiple Sclerosis that meets specific criteria, or if your CIS only affects your spinal cord. People with serious mental health conditions, severe memory problems, or a history of drug or alcohol abuse also can't take part. If you are pregnant or breastfeeding, or have other serious medical conditions that the study doctor thinks would make it unsafe for you to join, you won't be eligible.

Quick self-check

Are you 18 years old or older?
Do you have Clinically Isolated Syndrome (CIS) or recently diagnosed MS?
Have you avoided steroids or certain immune treatments in the last month?
Are you able to attend two visits in Exeter?
Are you (if female) using reliable birth control if you could get pregnant?
Do you not have a definite diagnosis of MS as per specific criteria?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will have two visits. During your first visit, you'll have a detailed chat with the study team to make sure you understand everything and give your consent. They will then do a thorough physical check-up, ask you some questions about your health and any symptoms related to CIS or MS, and you'll complete a few questionnaires.

You'll also provide some blood samples, which will be used to check your general health, look for markers related to CIS and the brain's cleaning system, and be stored for future research. Women who could become pregnant will also give a urine sample for a pregnancy test. The second visit will be at the Mireille Gillings Neuroimaging Centre at the University of Exeter. Here, you'll have a special MRI scan of your brain, which will last about 60 minutes. Throughout the study, if you are taking any medication to help with your immune system, you should have been on it for at least 30 days before joining and should not change your dose while you are in the study.

Potential risks and benefits

Taking part in research studies helps us learn more about health conditions, and while there might not be a direct benefit to you personally, the information gained could help others in the future by improving our understanding of MS. We don't expect any serious risks from the MRI scan, which is a common and safe procedure, but you'll have a detailed medical check before you start. Giving blood samples can sometimes cause minor bruising or discomfort. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom
University of Exeter
Exeter, United Kingdom

Common questions

What is the 'glymphatic system'?

It's like your brain's natural cleaning system that helps wash away waste products that build up. This study is looking at how well it works.

What is Clinically Isolated Syndrome (CIS)?

CIS is often the first set of neurological symptoms someone experiences, and it can sometimes be the very first sign that someone might develop Multiple Sclerosis (MS).

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your body, including your brain. It's a common and safe procedure.

How long will I be involved in the study?

You'll have two visits. The first visit involves checks and questionnaires, and the second visit is for the MRI scan, which lasts about an hour.

Will I get results from my scans or tests?

The study aims to gather overall information to help understand CIS and MS. Individual results may not be shared, but the overall findings will help future research.