RecruitingNAINTERVENTIONAL

The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology.

This study aims to understand why some people get migraines, especially those who also have certain autoimmune or inflammatory conditions like multiple sclerosis, rheumatoid arthritis, Crohn's disease, lupus, or endometriosis. Researchers believe that certain chemicals in the body, called cytokines, and special immune cells, known as regulatory T cells (Treg cells), play a role in migraine pain and inflammation. Currently, many people with migraines don't find relief from existing treatments, and the exact causes of migraine are still not fully clear. This research will compare levels of these chemicals and cells in people with and without migraines, both with and without these other health conditions, using a simple blood test. The findings could help us better understand migraines and potentially lead to new treatments in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

396

Start

02 Jun 2025

Estimated completion

30 Apr 2027

Migraine Disorders Pain Autoimmune Diseases Multiple Sclerosis Endometriosis Rheumatoid Arthritis Crohn Disease Lupus Erythematosus

What is this study about?

Migraine is a common and often very disruptive headache condition that affects many people, especially women. It's not just a bad headache; it can cause severe throbbing pain, sickness, and sensitivity to light and sound. Doctors have noticed that migraines are more common in people who also have other health problems where the body's immune system mistakenly attacks healthy tissues – these are called autoimmune or inflammatory diseases, such as multiple sclerosis (MS) or rheumatoid arthritis (RA).

Even though there are some new treatments for migraine, many people don't find them helpful, and we still don't fully understand what causes migraines. Scientists think that certain chemicals in the body called 'cytokines' (which are involved in inflammation) and special immune cells called 'regulatory T cells' or 'Tregs' (which help calm down inflammation) might be important. Previous studies have shown mixed results, so more research is needed to get a clearer picture.

This study will investigate these chemicals and cells more closely. Researchers will compare the levels of Treg cells and cytokines in women who get migraines and those who don't. They will also look at these levels in people who have migraines alongside conditions like MS, RA, Crohn's disease, lupus, type 1 diabetes, or endometriosis, and compare them to people without such conditions. By doing this, they hope to find out if there are specific patterns in these chemicals and cells that are linked to migraines, particularly in women with these other health issues. This could help us better understand the root causes of migraine.

Key takeaways

This study explores the link between migraines and the body's immune system.
It focuses on specific immune cells (Treg cells) and inflammation chemicals (cytokines).
Researchers are particularly interested in women with migraines and certain autoimmune conditions.
Participation involves a single blood test.
The goal is to better understand migraine causes, not to provide treatment.

Who may be eligible?

This study is looking for women between 18 and 50 years old who weigh at least 50 kg (around 7 stone 12 pounds). You might be eligible if you have migraines at least four days a month. They are also looking for women with specific autoimmune or inflammatory conditions, whether they have migraines or not. These conditions include multiple sclerosis, lupus, rheumatoid arthritis, Crohn's disease, type 1 diabetes, or endometriosis.

However, you wouldn't be able to join if you are pregnant, breastfeeding, or have recently had a baby or miscarriage. You'll also be excluded if you're undergoing fertility treatments that involve hormones, have gone through menopause, or have had certain surgeries like a hysterectomy. If you have type 2 diabetes, a weakened immune system, or certain other health conditions, or if you've had an organ transplant, you also can't take part. They are also carefully checking that participants either have migraines or specific autoimmune conditions, but not usually both, for the different groups being studied. If you are a healthy volunteer, you must not have migraines or any autoimmune disease.

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?
Are you between 18 and 50 years old?
Do you weigh at least 50 kg?
Do you experience migraines at least 4 days a month (if applying for the migraine group)?
Have you been diagnosed with Multiple Sclerosis, Lupus, Rheumatoid Arthritis, Crohn's Disease, Type 1 Diabetes, or Endometriosis (if applying for a specific condition group)?
Are you NOT pregnant, breastfeeding, or undergoing fertility treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve a simple blood test. The researchers will take a sample of your blood, and that's generally the main involvement required for this study. There won't be any study medications to take, hospital stays, or long follow-up appointments. The entire process of your participation for this particular study is focused on this blood sample to help understand the body's immune system activity.

Potential risks and benefits

Taking part in this study won't directly improve your migraine symptoms. However, by donating a blood sample, you'll be contributing important information that could help scientists better understand migraines and pave the way for new treatments in the future. As with any blood test, there's a small risk of minor discomfort, bruising, or, very rarely, infection at the site where the blood is drawn. You are free to withdraw from the study at any time without having to give a reason, and it won't affect your current or future medical care.

Locations (1)

CHU de Clermont-Ferrand - Service de Neurologie
Verified postcode
Clermont-Ferrand, France· Recruiting

Common questions

What is a 'cytokine'?

Cytokines are small proteins that act like messengers in your immune system, helping your body respond to infections and injuries, and sometimes contributing to inflammation.

What are 'Treg cells'?

Treg cells (regulatory T cells) are a type of immune cell that helps to keep your immune system in balance and stop it from overreacting, which can reduce inflammation.

Will I get any treatment as part of this study?

No, this study is observational, meaning it only involves a blood test to gather information, not to provide any treatment.

How long will my involvement in the study last?

Your involvement in the study will be very short, typically just the time it takes to have a blood sample taken. There are no long-term follow-up visits.

What will happen to my blood sample?

Your blood sample will be analysed in a lab to measure specific immune cells and chemicals related to inflammation and your immune system, to help researchers understand migraines better.

How to find out more

Lise LACLAUTRE

promo_interne_drci@chu-clermontferrand.fr 334.73.754.963 Official trial record

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