RecruitingNAINTERVENTIONAL

Safety of Splenic Stimulation for RA

This study is investigating a new approach for adults with rheumatoid arthritis (RA) that hasn't responded well to standard medicines. The research aims to check the safety of a new device, called the Galvani System, which gently stimulates an area near the spleen. This stimulation is hoped to help reduce RA symptoms. Five people will have a small device, similar to a pacemaker, implanted. They will then receive this nerve stimulation for 12 weeks. Researchers will closely monitor participants to ensure the device is safe and tolerable. If this early study shows promise, it could lead to new treatment options for people living with difficult-to-treat RA.

At a glance

Status

Recruiting

Phase

Sponsor

Galvani Bioelectronics

Enrolment target

Start

20 Oct 2021

Estimated completion

01 Apr 2029

Rheumatoid Arthritis

What is this study about?

This study is exploring a new way to help people with rheumatoid arthritis (RA). RA is a condition where your body's immune system mistakenly attacks your own joints, causing pain, swelling, and stiffness. We're looking for new treatments, especially for those who haven't found enough relief from current medications like biologics or JAK inhibitors.

This new approach involves a special device called the Galvani System. Think of it like a small, clever pacemaker, but instead of helping your heart, it aims to help your immune system. This device sends gentle electrical signals to a specific nerve area near your spleen. The spleen is an organ in your tummy that plays a big role in your immune system. The idea is that by stimulating this nerve, we might be able to calm down the overactive immune response that causes RA symptoms.

The main goal of this particular study is to see if this new device and the stimulation it provides are safe for people with RA and if patients can tolerate having it. It's a small, early-stage study, meaning we're not yet looking at how well it treats RA, but rather making sure it's safe to use. If it proves safe, it could open the door for larger studies to see how effective it is in reducing RA symptoms.

Key takeaways

This study is testing a new device that stimulates a nerve near the spleen to treat active rheumatoid arthritis.
It's for people whose RA hasn't improved with at least two other strong RA medicines.
The main goal is to check if the device is safe and tolerable.
Only five people will have the device implanted for 12 weeks of stimulation.
Your involvement would last about five months, followed by a potential long-term follow-up.
This is an early-stage study, exploring a new path for RA treatment.

Who may be eligible?

To be considered for this study, you would need to be an adult between 22 and 75 years old and have rheumatoid arthritis that started in adulthood. Your RA should still be active, meaning you're experiencing noticeable symptoms, even though you've already tried at least two different types of strong RA medications (like biologics or JAK inhibitors) and they haven't worked well enough for you, or you couldn't tolerate them.

There are also some important reasons why you might not be able to join. For example, if you've recently had certain other strong medications, or if you have other serious health problems like certain infections (such as HIV, Hepatitis B or C, or untreated tuberculosis), or if you've had cancer recently. We also can't include people who have other medical devices already implanted that use electricity (like a pacemaker), or if you've had your spleen surgically removed. Women who could become pregnant would also not be able to participate.

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 between 22 and 75 years old?
Do you have rheumatoid arthritis that is still active?
Have you tried at least two strong RA medications (like biologics or JAK inhibitors) that didn't work well enough?
Do you *not* have other serious health problems like certain infections or cancer in the last 5 years?
Do you *not* have any implanted electrical medical devices (like a pacemaker)?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey would last about five months in total. First, there's a screening period of about four weeks to make sure the study is a good fit for you. If you're eligible, you would then have a small operation to implant the Galvani System device. After the surgery, there will be a four-week recovery period.

Following recovery, you'll receive the nerve stimulation for 12 weeks. During this time, you'll need to visit the clinic on specific days for check-ups, so the research team can monitor your progress and ensure the device is working safely. If needed, the team might adjust the stimulation settings to see if it helps more. After the 12-week treatment period, you'll be invited to join a separate, longer-term study that will continue to follow your health for up to five years.

Potential risks and benefits

As this is a new type of treatment, the main benefit of taking part is potentially being among the first to receive a new approach for your rheumatoid arthritis, especially if other treatments haven't worked for you. It's important to remember that the main aim of this specific study is to check the device's safety, not necessarily how well it treats RA, although your RA symptoms will be monitored. Like any medical procedure, there are potential risks involved with the surgery to implant the device, such as infection or pain. There might also be unknown risks associated with the nerve stimulation itself. You will be fully informed about all known risks before deciding to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Verified postcode
Amsterdam, Netherlands· Recruiting
Greater Glasgow Health Board
Verified postcode
Glasgow, United Kingdom· Recruiting

Common questions

What is the Galvani System?

It's a new investigational device, similar to a small pacemaker, designed to send gentle electrical signals to a nerve near your spleen to help with rheumatoid arthritis.

Why is the spleen important for this study?

The spleen is involved in your body's immune system, and stimulating a nerve near it might help calm down the overactive immune response in rheumatoid arthritis.

How long will I be in the study if I participate?

The total active study period, from screening to the end of the treatment phase, is about five months. After that, you'll be invited to a longer follow-up study for up to five years.

Will this device cure my rheumatoid arthritis?

This early study primarily aims to check the safety of the device. While it's hoped to help with RA symptoms, it's not designed as a cure.

Can I continue my regular RA medications if I join?

The study will have specific rules about other medications you can take. If you're eligible, the study team will discuss this in detail with you.

How to find out more

Operations Director

clinical@galvani.bio +44 (0)800 3688514 Official trial record

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