Active not recruitingOBSERVATIONAL

Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients

This research study aims to find clearer ways to predict how Multiple Sclerosis (MS) might change over time for individuals. Researchers believe that certain measurements from blood tests and eye scans could be just as good as, or even better than, standard brain scans at predicting future increases in disability for people with MS. They will measure specific markers in the blood (neurofilament-light chain) and look at changes in a part of the eye (macular ganglion cell complex) using special imaging. These results will be compared with changes in brain size over time. The goal is to discover earlier and more straightforward ways to understand an individual's MS journey, which could lead to better management and treatment choices in the future, helping people prepare and adapt.

At a glance

Status

Active not recruiting

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

200

Start

25 Jun 2019

Estimated completion

01 Jun 2026

Multiple Sclerosis

What is this study about?

This study is about understanding Multiple Sclerosis (MS) better. MS is a condition that affects your brain and spinal cord. It can cause a range of symptoms, and these can change over time. Doctors are always looking for better ways to predict how MS might progress for each person, so they can offer the best advice and treatment.

Currently, one way doctors try to understand MS progression is by looking at changes in the size of the brain using special scans. This study wants to see if two other measurements could also be good at predicting these changes. They will measure something called 'neurofilament-light chain' (NfL) in your blood – this is a marker that can show if nerve cells might be damaged. They will also use a special eye scan to look at a part of your eye called the 'macular ganglion cell complex' (GCC) to see if its thickness changes over a year.

The main idea is to find out if these blood tests and eye scans can predict how your MS will affect your daily life and abilities in the future, just as well as, or even better than, full brain scans. If these new methods prove useful, it could mean doctors would have more tools to understand your MS more precisely and earlier. This could help make more informed decisions about your care and treatment plans.

Key takeaways

This study explores new ways to predict MS progression.
It uses blood tests and eye scans alongside traditional brain scans.
Aims to find earlier and simpler ways to understand how MS might change.
Participation involves MRI scans, eye scans, and blood tests over at least one year.
Your medical care will not be affected if you choose not to join or withdraw.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. You should have a diagnosis of MS that started less than 10 years ago. This includes if you've had a first episode that suggests MS (called CIS), or if you have relapsing-remitting MS, or if your MS is progressing, as long as your challenges with movement or other abilities, measured by a special scale, are not too severe.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you can't have an MRI scan (perhaps due to certain metal implants). You also wouldn't be able to take part if you've had an eye condition that affects both eyes or a recent MS flare-up (relapse) within the last three months. The study also cannot include you if you have certain other serious health issues, like severe mental health problems or serious alcohol use.

Lastly, your doctor needs to be able to fully explain the study to you, and you need to understand it and agree to take part by signing a consent form. This ensures you are fully aware of what the study involves and are happy to proceed.

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?
Was your MS diagnosed less than 10 years ago?
Are you able to have an MRI scan (no metal implants that prevent it)?
Have you *not* had an MS relapse in the last 3 months?
Are you *not* currently pregnant or breastfeeding?
Do you *not* have a severe eye condition affecting both eyes?

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. These will include MRI scans of your brain and spinal cord, which are special scans that take detailed pictures of these areas. You will also have eye scans, which look closely at the back of your eyes. These scans will likely happen at the beginning of the study and then again after one year. You will also have blood tests at these time points. The study involves tracking your condition over time, so there will be follow-up appointments to see how you are doing. The total duration of your active participation, including these scans and follow-ups, would be at least one year.

Potential risks and benefits

Taking part in research studies always has potential benefits and risks. A potential benefit of this study is that it might help improve our understanding of MS, which could lead to better ways to manage the condition for others in the future. For you personally, you will receive detailed health checks, including advanced scans of your brain, spinal cord, and eyes. The main risks involve the procedures themselves, such as the MRI scans which might be uncomfortable for some people or involve a small injection for contrast. There's also a small risk of discomfort from blood tests. You are free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (1)

CHU de Nimes
Verified postcode
Nîmes, France

Common questions

What is an MRI scan?

An MRI (Magnetic Resonance Imaging) uses strong magnets and radio waves to create detailed pictures of organs and structures inside your body, like your brain and spinal cord.

What is NfL?

NfL (neurofilament-light chain) is a small protein found in your nerve cells. When nerve cells are damaged, NfL can sometimes be found in your blood, making it a marker that researchers are studying for conditions like MS.

Will I get paid for participating?

The information provided does not state if participants receive payment. It's best to ask the study team directly.

What is the 'macular ganglion cell complex'?

This is a specific layer of nerve cells in a central part of your eye called the macula, which is important for sharp, central vision. The study will measure its thickness using a special scan.

How long will I be in the study?

The active part of the study mentioned includes assessments over at least a year, but the overall follow-up might be longer. You would need to clarify the exact duration with the study team.