Measuring Silent Disease Progression in Multiple Sclerosis With a Multimodal Approach
This study is for people with multiple sclerosis (MS) who are being treated with specific antibody medications. The main goal is to understand how MS can slowly get worse over time, even when there are no obvious relapses or flare-ups. This is often called 'silent progression'. To do this, researchers will check participants every six months with a doctor's examination and blood tests. Some participants will also have MRI scans once a year. Additionally, there's an option to use a smartphone and smartwatch to collect information about daily activities. By combining all this information, the study hopes to find new ways to spot this silent progression earlier and understand how it affects people living with MS.
At a glance
What is this study about?
This study is trying to understand a sneaky part of multiple sclerosis (MS) called 'silent progression'. You might know that MS often involves relapses, which are sudden new symptoms or a worsening of old ones. However, MS can also slowly progress over time, even when you're not having a relapse and are taking medication. This 'silent progression' can be hard to spot early, and doctors are keen to find better ways to detect it.
Today, many people with MS are on special antibody treatments. These treatments are very good at stopping relapses. Because relapses are better controlled, doctors are now more focused on understanding and treating this silent progression. This study believes that combining information from different sources – like your doctor's assessment, blood tests, brain scans, and even data from your smartphone or smartwatch – could give a clearer picture of what's happening.
The main aim is to see how well these different tests can pick up on silent changes in MS. By comparing the results from these tests with how participants feel they are progressing, the study hopes to find reliable ways to measure this slow worsening. Ultimately, this research could help doctors understand who is experiencing silent progression and how to help them sooner.
Key takeaways
- The study aims to understand slow MS progression, even without relapses.
- It involves regular doctor check-ups, blood tests, and optional MRI scans.
- Optional smartphone/smartwatch use can provide daily health information.
- Participants must be on specific antibody treatments for MS.
- The goal is to find better ways to detect and monitor silent MS changes.
- Your current MS treatment will continue as usual if you participate.
Who may be eligible?
This study is looking for adults aged 18 or older who have been diagnosed with either relapsing-remitting MS (RRMS) or primary progressive MS (PPMS). You need to be currently taking specific antibody treatments for your MS, such as Natalizumab, Ofatumumab, or Ocrelizumab. Also, your current level of disability from MS, as measured by a doctor, should not be too severe (specifically, a score of 7 or less on a scale called EDSS).
There are also some reasons why you wouldn't be able to join. For example, if you've recently had an MS attack or received strong steroid treatments in the last six weeks, you wouldn't be eligible. The study also can't include people who have other serious health problems that would make it difficult to understand or complete the study tasks, or if they are pregnant. If you're on other medications that suppress your immune system, apart from the MS antibodies, you also wouldn't be able to take part.
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?
- Have you been diagnosed with Relapsing-Remitting MS (RRMS) or Primary Progressive MS (PPMS)?
- Are you currently taking an antibody treatment for your MS (like Natalizumab, Ofatumumab, or Ocrelizumab)?
- Have you NOT had an MS relapse or strong steroid treatment in the last six weeks?
- Are you NOT pregnant and not on other immune-suppressing drugs apart from your MS antibody treatment?
- Do you feel you can understand and complete the study tasks?
What does participation involve?
If you decide to take part, you'll have regular check-ups every six months. During these visits, a doctor will examine you, and you'll have blood samples taken for special tests. Some participants will also have an MRI scan of their brain once a year. There's an extra, optional part where you can use a smartphone and a smartwatch to continuously collect information about your daily activity, sleep, and even how you type. The study plans to collect data over a period of time, but the exact total duration isn't specified, and you'll continue with your regular MS antibody treatment as usual throughout the study.
Potential risks and benefits
Locations (1)
- University Hospital Düsseldorf, Department of NeurologyVerified postcodeDüsseldorf, Germany· Recruiting
Common questions
What does 'silent progression' mean in MS?
It means your MS is slowly getting worse over time, even if you're not having obvious new relapses or flare-ups.
What kind of treatments do I need to be on for this study?
You need to be taking specific antibody treatments for your MS, like Natalizumab, Ofatumumab, or Ocrelizumab.
Do I have to wear a smartwatch or use a smartphone for the study?
No, using a smartphone and smartwatch to collect data is completely optional. You can still participate without doing this.
Will I have to stop my current MS medication if I join?
No, you will continue with your regular antibody treatment for MS as prescribed by your doctor throughout the study.
What is an MRI scan?
An MRI scan is a special type of scan that uses strong magnets and radio waves to create detailed pictures of your brain and other parts of your body.
How to find out more
Marc Günter Pawlitzki, PD Dr. med.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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