RecruitingNAINTERVENTIONAL

Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation

Many women of childbearing age experience endometriosis, which often causes severe pelvic pain, painful periods, and pain during sex. Even after surgery or other treatments, this pain can sometimes continue. This study is testing a non-invasive treatment called transcutaneous auricular vagus nerve stimulation (t-VNS). This involves placing a small device on the ear that sends gentle electrical signals to a nerve called the vagus nerve. Previous research suggests this nerve stimulation might help reduce inflammation and change how the body processes pain. Researchers have also seen promising results in a small number of patients with chronic pelvic pain. This study aims to conduct a larger, more structured trial to confirm if t-VNS can be an effective option for women whose endometriosis pain hasn't fully responded to other treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Hopital Foch

Enrolment target

Start

13 Dec 2021

Estimated completion

28 Mar 2027

Endometriosis

What is this study about?

Endometriosis is a condition where tissue similar to the lining of the womb grows elsewhere in the body, often causing significant pain. This can include very painful periods, ongoing pelvic pain, and discomfort during sex. Even with treatments like surgery, many women find their pain doesn't completely go away. Sometimes, the body becomes more sensitive to pain over time, making it harder to find relief.

This study is exploring a new approach called transcutaneous auricular vagus nerve stimulation (t-VNS). It's a non-invasive technique, meaning it doesn't involve surgery or injections. Instead, a small device is placed on the outer ear to deliver gentle electrical pulses to a specific nerve called the vagus nerve. This nerve plays a role in many body functions, including affecting inflammation and how our brains process pain signals. Previous studies have shown vagus nerve stimulation can be helpful for conditions like migraines and depression, and there's some early evidence it could also help with chronic pelvic pain.

The main aim of this study is to see if t-VNS can effectively reduce pain in women with endometriosis who haven't found enough relief from their current treatments. The researchers have already seen some encouraging results with this technique in a few patients, and they now want to carry out a more thorough study to confirm these findings. If successful, t-VNS could offer a new, gentle way to manage persistent pain for women living with endometriosis.

Key takeaways

This study explores a non-invasive treatment for endometriosis pain.
It uses a gentle electrical stimulation on the ear (t-VNS).
It's for women whose pain hasn't been fully controlled by other treatments.
The treatment aims to reduce pain by affecting nerve signals and inflammation.
Early results have been promising, leading to this larger study.

Who may be eligible?

This study is looking for women aged 15 and over who are currently experiencing ongoing pelvic pain, painful periods, or pain during sex due to endometriosis. You must have been seen by a gynaecologist at one of the hospitals involved in the study and have a formal diagnosis of endometriosis. You should also be enrolled in a health insurance scheme and be able to give your informed consent to take part.

There are certain reasons why you might not be able to join the study. For example, if you have any heart problems or asthma, as these can be affected by the stimulation. Pregnant or breastfeeding women, or those undergoing IVF treatment, cannot participate. If you need long-term pain medication for another condition, or have had a similar type of nerve stimulation in the last year, you would also not be eligible. Finally, people who are detained or under guardianship cannot take part.

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 female and aged 15 or older?
Do you have ongoing pelvic pain, painful periods, or pain during sex due to endometriosis?
Has a gynaecologist diagnosed you with endometriosis?
Are you NOT pregnant or breastfeeding, and not undergoing IVF?
Do you NOT have heart problems or severe asthma?
Have you NOT had a similar nerve stimulation treatment in the last 12 months?

Answer every question to see your result.

What does participation involve?

The detailed plan for participation isn't provided in full, but generally, taking part in a study like this might involve a screening visit to check if you're eligible. If you are, you would then agree to join by signing a consent form. The study will likely involve regular appointments for treatment sessions and assessments to measure your pain levels and any changes in your condition. You would receive the t-VNS treatment on a specific schedule, and the researchers would monitor your progress over time. The total length of your participation would be explained to you before you agree to join.

Potential risks and benefits

Participating in this study might offer you the potential benefit of finding a new way to manage your endometriosis pain, especially if other treatments haven't fully helped. While t-VNS is generally considered safe, potential risks might include mild skin irritation where the device is placed, or perhaps some temporary discomfort. More serious side effects are rare but would be fully explained to you. You are free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Hopital Foch
Verified postcode
Suresnes, France· Recruiting

Common questions

What is endometriosis?

Endometriosis is a condition where tissue similar to the lining of the womb grows outside it, often causing pain, especially in the pelvis.

What is t-VNS?

t-VNS stands for transcutaneous auricular vagus nerve stimulation. It's a gentle electrical treatment applied to the ear to stimulate a nerve that affects pain and inflammation.

Is t-VNS a new treatment?

While vagus nerve stimulation has been used for other conditions, its use for endometriosis pain is still being studied in trials like this one to confirm its effectiveness.

Will this cure my endometriosis?

This study aims to see if t-VNS can help manage the pain associated with endometriosis, but it is not expected to cure the condition itself.

Do I have to stop my current pain medication?

The study details don't specify, but typically researchers will discuss your current medications and how they might fit with the study treatment. Some pain medications may exclude you from participation.

How to find out more

Mireille MICHEL-CHERQUI, MD

drci.promotion@hopital-foch.com 0033 1 46 25 29 85 Official trial record

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