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RecruitingPhase IIInterventional

A preliminary study investigating if muscle stimulation as an exercise therapy for people with multiple sclerosis helps strengthen muscles, improves walking, helps with tiredness, and reduces spasms

This study is investigating if a special type of muscle stimulation can help people with Multiple Sclerosis (MS) who experience muscle weakness, walking difficulties, and tiredness. MS is a condition that affects the brain and nerves, making daily activities challenging. The muscle stimulation device sends gentle electrical signals to make muscles contract, similar to exercise. Participants will use this device at home for 12 weeks. Researchers want to see if this helps strengthen muscles, improves walking, and reduces tiredness and muscle spasms. This is a small, early-stage study designed to gather information to help plan a larger study in the future. It's hoped that this research could eventually lead to new ways for people with MS to stay active and independent.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
University of Liverpool
Enrolment target
64
Start
03 Oct 2025
Estimated completion
03 Jan 2027

What is this study about?

Multiple Sclerosis (MS) is a health condition where the body's immune system mistakenly attacks its own brain and nerves. This damage can lead to various problems, including muscles feeling weak or tired, balance issues, and difficulty walking. Many people with MS find exercising a challenge because of these symptoms, or because they lack confidence or need help.

This study is looking into whether a technique called muscle stimulation could be helpful for people with MS. This involves placing sticky pads on the skin, usually on the legs, which then send gentle electrical signals to make the muscles contract. It's a bit like doing exercise with weights, but the device helps your muscles do the work. The idea is that this could help muscles get stronger, make walking easier, boost physical activity levels, and reduce feelings of tiredness.

The main goal of this particular study is to collect enough information to help researchers plan a much larger study in the future. They want to find out if muscle stimulation really can make a difference in strengthening muscles, improving walking, making people feel less tired, and reducing muscle spasms for those living with MS.

Key takeaways

  • It's a study testing muscle stimulation for MS symptoms.
  • Aims to improve walking, strength, and reduce tiredness/spasms.
  • Participants use a home device for 12 weeks (if in that group).
  • It's a small, early-stage study to plan future research.
  • No guaranteed direct benefits, but helps future patients.
  • Involves regular check-ups over 6 months.

Who may be eligible?

This study is looking for people with any type of Multiple Sclerosis (MS) who are over 18 years old. To take part, you should have some difficulties with walking, but still be able to walk at least 20 metres (about the length of two double-decker buses) without stopping for a rest. You can use walking aids like a stick or crutches if you normally do.

There are also some reasons why you might not be able to join. For example, if you've recently had an MS flare-up, have certain nerve injuries or very stiff joints in your legs, or have specific health conditions like uncontrolled epilepsy or are pregnant, you wouldn't be able to participate. If you have a heart pacemaker, you might still be able to join, but your heart doctor would need to approve it first. The researchers want to make sure it's safe for everyone involved.

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.

  1. Do I have any form of Multiple Sclerosis (MS)?
  2. Am I able to walk at least 20 metres (with or without aids) without stopping?
  3. Am I at least 18 years old?
  4. Am I free from serious heart problems, active MS flare-ups, or skin infections where the pads would go?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of 50 people with MS taking part from hospitals in Liverpool and Wolverhampton. A computer will randomly decide whether you receive muscle stimulation alongside your usual care, or if you continue with your usual care only. If you're in the muscle stimulation group, you'll use a special device on your legs at home for 12 weeks.

Throughout the study, at the start, after 3 months, and again after 6 months, researchers will check your muscle strength, how well you walk, any muscle spasms you have, and how tired you feel. Both you and your carers, as well as the doctors and nurses involved, will be asked about your experiences with the study. The study is expected to run from November 2024 to October 2027.

Potential risks and benefits

There are no guaranteed personal health benefits from taking part in this early study. However, your involvement is very important because you'll be helping researchers gather vital information to design a larger future study. This bigger study would then aim to find out if muscle stimulation can truly help people with MS walk better, get stronger, and feel less tired. Possible downsides include the chance of not being in the group you might prefer. The sticky pads used for stimulation could cause some temporary skin redness or irritation, and the sensation might feel a bit strange at first, but people usually get used to it quickly. You'll also need to dedicate some time for hospital visits and filling out questionnaires. Remember, you are always free to leave the study at any time.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The Walton Centre NHS Foundation Trust
    City only
    Liverpool, England
  • The Royal Wolverhampton NHS Trust
    City only
    Wolverhampton, England

Common questions

What is muscle stimulation?

It's a way to make your muscles contract using gentle electrical signals sent through sticky pads on your skin, similar to exercising.

Will this study cure my MS?

No, this study is not looking for a cure. It aims to see if muscle stimulation can help manage some MS symptoms like weakness and walking difficulties.

Where does the study take place?

The study is being run from two hospital clinics in Liverpool and Wolverhampton.

How long will I be involved in the study?

You'll be part of the study for 6 months, with checks at the start, 3 months, and 6 months.

Who is paying for this research?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Fraser Philp

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

Discussion

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