Active not recruitingOBSERVATIONAL

Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

This research study is about a device called the Evoke Spinal Cord Stimulation (SCS) system, which is used to help people manage long-term pain in their body or limbs. The study aims to understand how well this system actually works over a long period, its safety, and how it performs in real-world situations. It’s for people who live with chronic pain and are already considered suitable for this type of treatment. By looking at a wide range of patients, the researchers hope to gather important information about this pain management option. This information will help doctors and patients make informed decisions about using the Evoke system for chronic pain.

At a glance

Status

Active not recruiting

Sponsor

Saluda Medical Pty Ltd

Enrolment target

Start

05 Aug 2020

Estimated completion

31 Dec 2028

Chronic Pain

What is this study about?

If you're living with ongoing pain in your body or limbs, you know how challenging it can be. This study is all about understanding a treatment option called the Evoke Spinal Cord Stimulation (SCS) system. Spinal cord stimulation involves a small device, similar to a pacemaker, that sends mild electrical pulses to your spinal cord. These pulses can help to interrupt pain signals before they reach your brain, potentially reducing the feeling of pain.

The main goal of this particular study is to see how well the Evoke system works over a long time for people like you. Doctors want to know if it consistently helps reduce pain, if it's safe to use in everyday life, and if people find it a good way to manage their chronic pain. This kind of research is really important because it helps improve pain treatments and gives doctors a clearer picture of what works best for patients.

By including many different people from various places, the study aims to get a broad understanding of the Evoke system’s effects. The information gathered will be used to help future patients and healthcare professionals understand the long-term benefits and any potential challenges of using this system. It's about making sure that treatments for chronic pain are as effective and safe as possible.

Key takeaways

The study looks at long-term effects of the Evoke SCS system for chronic pain.
It aims to understand safety and effectiveness in real-world use.
Participation involves receiving the Evoke system and having long-term follow-up.
Potential benefit is long-term pain relief.
Potential risks are associated with surgical implantation and device use.
You can leave the study at any time.

Who may be eligible?

This study is looking for people who are experiencing ongoing pain in their body or limbs. To join, you would need to be considered a good candidate for the Evoke Spinal Cord Stimulation (SCS) system by your doctor, meaning the treatment fits your particular situation based on how the device is designed to be used.

It's important that you are able to understand what the study involves and are happy to give your permission to take part. You also need to be willing and able to follow all the study's instructions and attend any necessary appointments. Your pain level in your main area of pain would need to be at a certain uncomfortable level before starting, specifically measured as 60mm or higher on a special pain scale (like a ruler).

There aren't any specific reasons given why you might not be able to join, beyond what's mentioned above. Essentially, if your doctor thinks the Evoke system is suitable for you, your pain is at a certain level, and you're happy to commit to the study, then you might be able to take part.

Quick self-check

Do I have chronic pain in my body or limbs?
Has my doctor suggested that spinal cord stimulation might be right for me?
Am I able to understand and agree to take part in a research study?
Can I commit to attending study appointments and following instructions?
Is my pain often quite strong (a 6 or more out of 10 average)?
Am I happy to have a device implanted to help manage my pain?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you would first have a full assessment to make sure the Evoke system is right for your pain. The Evoke system involves a minor procedure to implant the device. After the system is in place, you would have regular check-ups with the study team. These visits would be to monitor your pain levels, see how the system is working for you, and check for any side effects or issues. You wouldn't be given any new or experimental medications as part of this study, as it's focused on the long-term use of the Evoke system itself. The total duration of the study focuses on long-term follow-up, so you would be involved for an extended period, with ongoing assessments to track your progress and system performance.

Potential risks and benefits

Taking part in this study could potentially offer you a long-term solution for managing your chronic pain, improving your quality of life. However, as with any medical procedure, there are potential risks associated with the Evoke system implantation, such as infection, bleeding, or issues with the device itself. The study team will closely monitor you to address any concerns. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

AZ Nikolaas Multidisciplinary Pain Center
Sint-Niklaas, Belgium
AZ Delta Multidisciplinary Pain Center
Roeselare, Belgium
Universität Düsseldorf
Düsseldorf, Germany
Erasmus University Medical Center
Rotterdam, Netherlands
Rijnstate
Velp, Netherlands
Basildon University Hospital
Basildon, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Southmead Hospital
Bristol, United Kingdom

Common questions

What is the Evoke Spinal Cord Stimulation (SCS) system?

It's a small device implanted in your body that sends mild electrical pulses to your spinal cord to help reduce chronic pain.

Who can take part in this study?

This study is for adults with ongoing body or limb pain who have been told by their doctor that the Evoke system might be a suitable treatment for them, and who are able to follow the study rules.

What kind of pain is this study looking at?

It's for people who have chronic (long-lasting) pain in their body or limbs.

Will I have to take new medicines in this study?

No, this study is about how well the Evoke system works over time, not about new medications.

How long will I be in the study?

This is a long-term study, so you would be monitored over an extended period to see how the system performs over time.