RecruitingNAINTERVENTIONAL

Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation

This research trial aims to find out if a treatment called Deep Brain Stimulation (DBS) can effectively reduce severe pain that some adults experience after a stroke, even when other treatments haven't helped. It also investigates how safe DBS is for this group of people. Participants will have an MRI scan and then undergo brain surgery to have the DBS system fitted. Over about 10 months, they will visit a clinic at least five times for check-ups and tests, and also complete questionnaires about their pain and mood. Researchers will turn the stimulation on and off at different times to see the effect it has, without participants knowing which setting is active. The main goal is to see if DBS can lower pain scores and what side effects, if any, people experience.

At a glance

Status

Recruiting

Phase

Sponsor

University of Oxford

Enrolment target

Start

07 Aug 2024

Estimated completion

01 Dec 2028

Central Post Stroke Pain

What is this study about?

This study, called EPIONE, is investigating a treatment known as Deep Brain Stimulation (DBS) for adults suffering from very severe and ongoing pain after a stroke. This type of pain is often called Central Post Stroke Pain and it can be very difficult to treat with standard medications or other approaches. The main reason for doing this research is to see if DBS can effectively reduce this pain and improve people's quality of life. It's also really important to understand any potential side effects or safety concerns linked with the procedure.

The researchers want to compare having the DBS device switched on with a 'pseudo-on' setting, where participants don't know if the device is actively stimulating or not. This helps them get a very clear picture of whether DBS truly makes a difference to pain levels. They will also explore different settings of the DBS device to find out which ones work best. Over time, the device settings might even be adjusted to suit individual needs, perhaps changing during sleep or movement based on what's best for each person.

While some smaller studies in the past have suggested DBS might help with this kind of pain, they weren't conducted to the same strict standards as modern research. This means we don't have enough clear evidence yet. This new trial aims to provide robust, high-quality information to confirm if DBS is a safe and effective option for people living with severe post-stroke pain that hasn't responded to other treatments.

Key takeaways

Looks at DBS for severe, long-term stroke pain.
Compares active DBS with an inactive setting to see real benefits.
Involves brain surgery to implant the DBS device.
Requires about 10 months of follow-up and clinic visits.
Aims to find out if DBS can lower pain scores and is safe.
Designed for people whose pain hasn't responded to other treatments.

Who may be eligible?

To be considered for this study, you would need to be 21 years old or older. You must have had pain from a stroke that has lasted for at least two years and is severe, meaning it usually scores higher than 6 out of 10 on a pain scale, and hasn't improved much with other treatments given by a team of specialists. You also need to be willing and able to travel to Oxford for procedures and follow-up appointments, and understand and agree to take part in the study.

There are also reasons why someone might not be able to join the study. For example, if you have certain heart conditions or other serious health problems that would make surgery risky, or if you've already had a DBS device implanted. You also couldn't take part if you have conditions that prevent you from having an MRI scan, or if you have a bleeding disorder that would make surgery unsafe. Major mental health issues that aren't being treated or problems with understanding the study, or if you are pregnant or planning to be, would also prevent you from joining.

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 21 years old or older?
Have you had severe pain from a stroke for at least 2 years?
Does your pain usually score above 6/10 despite other treatments?
Can you travel to Oxford for appointments and surgery?
Are you able and willing to follow the study procedures?
Do you have any serious health conditions that would make surgery risky?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first have a health check and an MRI scan of your brain. Then, you will have surgery to have the DBS system fitted. After the surgery, you will be followed up for about 10 months. During this time, you will visit the clinic in Oxford at least 5 times for check-ups and tests. You'll also be asked to fill in questionnaires about your pain and mood, which can sometimes be done from home. The researchers will adjust the DBS settings over time to see what works best for you.

Potential risks and benefits

The potential benefits of taking part could include a significant reduction in your severe pain, which could improve your daily life and mood, especially if other treatments haven't worked. However, like any surgery, inserting the DBS device carries risks, such as those associated with general anaesthesia or potential complications from brain surgery. There could also be side effects from the device itself, though these are carefully monitored. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

John Radcliffe Hospital
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is Deep Brain Stimulation (DBS)?

DBS involves placing small wires into the brain, which are connected to a device similar to a pacemaker, hidden under the skin. This device sends electrical signals to specific areas of the brain to help manage symptoms like pain.

What does 'Central Post Stroke Pain' mean?

This is a type of long-lasting pain that some people experience after having a stroke. It's caused by damage to the brain from the stroke itself, rather than by problems with muscles or joints.

Will I know if the DBS device is switched on or off?

No, during parts of the study, you won't know if the device is actively stimulating or if it's set to a 'pseudo-on' mode. This is done to help the researchers accurately measure its effects.

How long will I need to be involved in the study?

After your surgery, you will be followed up for approximately 10 months, with at least 5 clinic visits during that time, plus some remote check-ups.

What if my pain doesn't improve?

The study aims to find out if DBS works for this type of pain. There's no guarantee it will improve everyone's pain, but the results will help us understand more about this treatment.

How to find out more

Alexander Green, MD, DPhil

alex.green@nds.ox.ac.uk +441865234762 Official trial record

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