RecruitingPHASE3INTERVENTIONAL

The Role of Peripheral Afferents in Modulating Post-stroke Central Pain

This research is investigating lasting pain that can happen after a stroke, known as central post-stroke pain, which is often hard to treat. Traditionally, this pain is thought to come from the brain or spinal cord, but recent ideas suggest nerves in the body might also play a role. The study will compare two different nerve-blocking medicines (lidocaine and levobupivacaine) with a dummy treatment (saline) to see if they can reduce this pain. Participants will receive two nerve blocks, two weeks apart, and their pain will be monitored closely for a month to understand which treatment, if any, is most effective.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Enrolment target

Start

09 Feb 2024

Estimated completion

08 Sep 2026

Stroke

What is this study about?

This study is looking into a type of long-lasting pain called central post-stroke pain, which can develop after someone has a stroke. This pain can be really tough to live with and often doesn't respond well to usual pain medications. Scientists don't fully understand why some people get this pain and why it's so hard to treat, which is why more research is needed.

Traditionally, it's been thought that this pain comes from changes in the brain or spinal cord. However, some newer research suggests that problems with the nerves outside the brain and spinal cord – in your arms or legs, for example – might also play a part. This study aims to explore that idea further.

The main goal is to see if temporarily blocking these 'peripheral' nerves can help reduce the pain. The study will compare two different medicines, lidocaine and levobupivacaine, with a 'dummy' treatment (a saltwater solution, called saline) to see which, if any, works best. This is an important step in finding better ways to manage this challenging pain for stroke survivors.

Key takeaways

This study explores new treatments for a specific type of stroke pain.
It tests two nerve-blocking medicines against a dummy treatment.
Participation involves two injections, two weeks apart, and pain monitoring.
The study aims to understand if nerves outside the brain play a role in this pain.
Your pain level will be closely tracked for up to a month.

Who may be eligible?

To join this study, you need to be at least 18 years old and have had a stroke at least 6 months ago. The pain you're experiencing must be in an arm or leg, and it needs to be the type of pain that doctors call 'neuropathic' post-stroke central pain. Your pain level should be 4 out of 10 or higher. You'll also need to be able to understand the study and agree to take part by signing a consent form.

There are some reasons why you might not be able to join. For example, if you have certain mental health conditions, are pregnant or breastfeeding, have serious kidney or liver problems, or are allergic to the medicines used in the nerve blocks. If your pain is spread across a very large area, or you have an infection where the block would be given, you wouldn't be able to participate. You also can't be taking part in other studies that might affect the results of this one.

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?
Did you have a stroke at least 6 months ago?
Do you have ongoing pain in an arm or leg?
Is your pain rated 4 out of 10 or higher?
Are you able to agree to take part and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to receive one of three treatments: lidocaine, levobupivacaine, or a dummy treatment (saline). Neither you nor the study doctors will know which treatment you are getting. You will have two separate visits, two weeks apart, where a specialist doctor will give you a nerve block injection.

Before each injection and at specific times afterwards (45 minutes and 5 hours), your pain will be measured. For the two weeks following each injection, you'll be asked to keep a daily diary of your pain. The study will last for about one month in total, from your first injection to the final follow-up after the second. During this time, the research team will also check for any side effects you might experience.

Potential risks and benefits

Taking part in this study could potentially help us understand more about or even reduce your pain, but there's no guarantee the treatment will work for you. There might be some side effects from the nerve blocks, such as bruising, numbness, or a temporary weakness where the injection was given, or a very rare chance of an allergic reaction. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

CHU Ambroise Paré
Verified postcode
Boulogne-Billancourt, France· Recruiting
Hôpital Raymond Poincaré
Verified postcode
Garches, France· Recruiting

Common questions

What is central post-stroke pain?

It's a long-lasting pain that can develop after a stroke, often in the areas of the body affected by the stroke.

What is a nerve block?

It's an injection that temporarily numbs or turns off specific nerves to stop pain signals.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor the doctors will know if you're getting an active medicine or the dummy treatment.

How long will the study last?

Your participation in the study will last for about one month in total.

Can I stop participating if I want to?

Yes, you can withdraw from the study at any time without needing to give a reason.

How to find out more

VALERIA MARTINEZ, MD

valeria.martinez@aphp.fr 01 47 10 76 22 Official trial record

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