Not yet recruitingNAINTERVENTIONAL

Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies

This study is investigating a new treatment for axial spondyloarthritis, a type of arthritis affecting the spine, for people whose condition hasn't improved with common medications, including special 'biotherapy' drugs. The treatment involves a gentle electrical stimulation of a nerve in the ear, known as Vagus Nerve Stimulation (VNS). Participants will receive either the active VNS treatment or a 'placebo' (dummy) stimulation, and then switch. This helps researchers understand if the active treatment truly makes a difference. They'll be checking various aspects of the disease, like pain, stiffness, and how well people can move, as well as their general quality of life. The aim is to find out if this non-drug treatment could be a new way to help manage this challenging condition.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

120

Start

01 Sep 2025

Estimated completion

01 Dec 2026

Axial Spondyloarthritis

What is this study about?

This research study is looking into a potential new way to help people who have a condition called axial spondyloarthritis. This is a type of arthritis that mainly affects the spine, causing pain, stiffness, and sometimes damage to the joints. For many people, existing treatments work well, but for some, even strong medications like 'biotherapies' don't provide enough relief. This study focuses on those individuals who are still struggling with their symptoms.

The new approach being tested is called Vagus Nerve Stimulation (VNS). It involves sending very gentle electrical pulses to a specific nerve in the ear, called the vagus nerve. This nerve is part of your body's control system and is involved in many important functions, including how your immune system works and how your body handles inflammation. Previous research suggests that stimulating this nerve might help calm down the inflammation that causes arthritis symptoms.

The main goal of this study is to see if VNS can improve symptoms and reduce the activity of axial spondyloarthritis after 8 weeks of treatment, compared to a 'placebo' or dummy stimulation. They will be looking at things like pain, stiffness, how well you can move, and your overall well-being. By doing this, the researchers hope to determine if VNS could offer a new, non-drug option for people who haven't found enough relief from their current treatments.

Key takeaways

Tests a new non-drug treatment (VNS) for axial spondyloarthritis.
Aimed at people who haven't found relief from other strong medicines.
Involves gentle electrical stimulation to a nerve in the ear.
Participants will receive active and 'dummy' stimulation at different times.
Study length is 16 weeks of stimulation, with weekly 1-hour sessions.
Could offer a new option if current treatments aren't working.

Who may be eligible?

To join this study, you need to be an adult between 18 and 90 years old and have been diagnosed with axial spondyloarthritis for at least a year. Your condition should still be active, meaning you have ongoing pain and stiffness, even if you’ve been taking regular medications for it. Crucially, your current treatments, including strong medicines like 'biotherapies', should not have fully relieved your symptoms.

There are also some reasons why you might not be able to join. For example, if you have certain heart problems like an irregular heartbeat, or if you've had a head injury that fractured your skull. Pregnant or breastfeeding women, people with cochlear implants, or those who have had VNS treatment before are also unable to take part. The researchers will check for any skin issues on your left ear, as this is where the treatment is applied, but this might just mean your participation is delayed until your skin heals.

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 18 and 90 years old?
Have you been diagnosed with axial spondyloarthritis for at least a year?
Are your spondyloarthritis symptoms still active despite regular treatment?
Have strong medicines (like biotherapies) not fully helped your symptoms?
Do you have any heart conditions or a cochlear implant?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be seen by a doctor who will explain everything and make sure you meet the study's requirements. Once you agree to participate, you'll be placed into one of two groups by chance – like flipping a coin. One group will receive the active VNS treatment for 8 weeks, followed by 8 weeks of a 'placebo' (dummy) stimulation. The other group will do the opposite: 8 weeks of placebo, then 8 weeks of active VNS. This 'switching' helps the researchers compare the effects accurately.

The VNS treatment involves a small device that gently stimulates a specific spot in your left outer ear for one hour each week. The placebo stimulation will feel similar but will be applied to a different, inactive spot on your ear. You'll have regular appointments throughout the study periods for assessments, which will involve filling out questionnaires about your symptoms and quality of life, as well as giving blood samples. The research team will ensure that the people giving you the stimulation are different from those checking your progress, and everyone involved will be unaware of whether you're receiving active or placebo treatment. The total duration of the stimulation periods will be 16 weeks, plus initial and final check-ups.

Potential risks and benefits

Taking part in this study might offer some potential benefits, as VNS could help reduce your pain and stiffness, and improve your overall well-being if it works for you. However, as with any new treatment, there's no guarantee that you will personally benefit. Potential risks are generally mild and temporary, such as slight skin irritation where the device is placed or discomfort during stimulation. The study is carefully monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP
Verified postcode
Garches, France

Common questions

What is Vagus Nerve Stimulation (VNS)?

VNS is a gentle electrical treatment applied to a nerve in your ear, which researchers hope might help reduce inflammation and pain.

Will I know if I'm getting the real treatment or the dummy treatment?

No, neither you nor the doctors assessing you will know at the time. This is important for ensuring the study results are fair and accurate.

How long does each treatment session last?

Each stimulation session lasts for one hour, and you will have one session per week.

What if I feel uncomfortable during the stimulation?

The stimulation intensity is very low, and you can discuss any discomfort with the study team who will be able to adjust it or provide advice.

Can I continue my regular medications during the study?

Generally, yes, but the study team will discuss all your current medications with you to ensure they don't interfere with the study or your safety.

How to find out more

Eric AZABOU, MD, PhD

eric.azabou@aphp.fr + 33 1 47 10 79 40 Official trial record

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