AuthorisedTherapeutic exploratory (Phase II)Interventional

Upper-limb Active Function and Botulinum Toxin A

This clinical trial is investigating whether a medication called Dysport, which is like Botox, can help people who have experienced a stroke and now have stiff or tight muscles in their arm. This stiffness often makes it difficult to move the arm freely. The study aims to measure how much this treatment reduces a problem called 'co-contraction,' where different muscles in the arm work against each each other, making movement harder. They will also look at whether it improves overall arm function and movement. This is an early-stage study (Phase II) to explore if this treatment could be helpful before larger studies are done. Participants will receive an injection and have their arm movements and brain activity checked before and after to see any changes.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Toulouse

Enrolment target

Start

31 Oct 2024

Stroke

What is this study about?

If you've had a stroke, you might experience muscle stiffness, weakness, or difficulty controlling your movements, especially in your arm. This can make everyday tasks challenging. Sometimes, after a stroke, muscles that should relax when you try to move actually tighten up at the same time as the muscles you're trying to use. This is called 'co-contraction,' and it can really get in the way of smooth, easy movement.

This study wants to explore if a medicine called Dysport, which is similar to Botox, can help with this specific problem in the elbow. Dysport works by relaxing overly tight muscles. Researchers will give participants an injection of Dysport into their arm muscles and then carefully measure how well their arm moves and if the co-contraction has improved.

They'll also be looking at other important aspects like how much the arm can straighten, overall arm and hand function, and even brain activity related to movement. The aim is to see if Dysport can make a real difference in helping people regain more control and movement in their arm after a stroke. This is a discovery phase study, meaning they are investigating if this treatment has potential benefits that warrant further, larger research.

Key takeaways

This study explores a treatment (Dysport) for arm stiffness after a stroke.
It aims to improve arm movement and reduce muscle counter-pulling.
Measurements will be taken before and about 4 weeks after an injection.
The study also looks at how brain activity changes with treatment.
It's a Phase II study, meaning it's an early look at potential benefits.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There's no upper age limit, meaning older adults are also welcome to take part. The study is open to both men and women.

The main requirement is that you have experienced a stroke that has caused some stiffness or difficulty with movement in one of your arms, specifically in the muscles around your elbow. This study focuses on how a medication can help with these specific arm movement challenges after a stroke.

Specific medical details about your stroke and overall health will be checked by the study doctors to make sure it's safe for you to participate and that your condition fits what the researchers are looking for. They'll review your medical history carefully.

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 had a stroke?
Does your stroke affect the movement or cause stiffness in your arm/elbow?
Are you able to attend appointments at the study site?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given an injection of the study medicine, Dysport, into specific muscles in your arm around the elbow. Before this, and about four weeks after the injection, researchers would take several measurements.

These measurements include using a special test called EMG, which records the electrical activity of your muscles to see how they're working together (or against each other) during arm movements. They'll also check your arm's stiffness (spasticity), how far you can move your elbow, and your overall arm function during tasks. You might also have tests that look at your brain activity during movement, using special equipment like EEG and TMS, and possibly an MRI scan to look at your brain's structure.

Each visit will involve these different assessments, and the entire study would likely involve a few appointments over a period of about a month or more, focusing on your condition before the injection and then seeing the effects approximately four weeks later.

Potential risks and benefits

Potential benefits of taking part could include possible improvement in your arm movement, reduced muscle stiffness, and better ability to perform daily tasks. You would also be contributing to medical research that could help many other people who have had a stroke. As with any medical procedure, there are potential risks, such as discomfort or bruising at the injection site, or other side effects from the medication. The research team will explain all known side effects in detail. It's very important to remember that participating 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 (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Dysport?

Dysport is a medicine similar to Botox. It works by relaxing muscles that are too tight or stiff, which can happen after a stroke.

What is 'co-contraction'?

Co-contraction is when different muscles in your arm, like those that bend and straighten your elbow, unknowingly tighten at the same time, making movements difficult.

Will I have to have brain scans?

Some parts of the study involve looking at brain activity (EEG, TMS) and structure (MRI) to understand more about how the brain recovers and responds to treatment. Not all participants may need all tests.

How long will the study effects last?

This study measures effects up to four weeks after the injection. The effects of medicines like Dysport typically wear off over a few months, and this study isn't designed to provide long-term treatment.

Do I have to pay to join?

No, all aspects of the study, including the medication and tests, are provided at no cost if you are eligible and choose to participate.