RecruitingNot ApplicableNCT06426316

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

Immune System, Inflammation, Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology


Sponsor

University Hospital, Clermont-Ferrand

Enrollment

396 participants

Start Date

Jun 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Migraine is a frequent and debilitating neurologic disorder. It is more frequent in women, and more prevalent in patients with autoimmune and/or inflammatory diseases such as multiple sclerosis (MS), rheumatoid arthritis (RA), Crohn's disease (CD), systemic lupus erythematosus (SLE) and endometriosis, whereas patients with long standing type 1 diabetes mellitus (T1DM) - an autoimmune but non inflammatory disease - seem to be less affected compared to the general population. Despite new migraine prevention treatments, a large number of patients remain unresponsive to currently available anti-migraine therapy and migraine pathophysiology remains unclear. Several peptides (calcitonin gene-related peptide (CGRP), pituitary adenylate cyclase activating peptide-38 (PACAP-38), vasoactive intestinal polypeptide (VIP)) and hormones (estrogens, prolactin) and the immune system play an important role in migraine pathophysiology. Among T lymphocytes, regulatory T (Treg) cells suppress inflammation. Studies have evidenced higher levels of inflammatory molecules (cytokines) in migraine patients and have suggested decreased proportions of Treg cells in migraine, as well as in MS, RA, CD and SLE, whereas inflammation declines and Treg levels seem increased in long-standing T1DM. Inflammation, which participates in migraine pain, seems to be a common factor for migraine and these diseases. However, these studies display conflicting results and further investigation is required to better understand the mechanisms behind migraine. In this study, the investigators will compare Treg levels, as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmune/inflammatory disorder (MS, RA, CD, SLE, T1DM and endometriosis).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at the role of certain immune proteins (cytokines) and regulatory immune cells (T lymphocytes) in migraine. It is comparing immune markers in women with migraine to women with autoimmune conditions (like multiple sclerosis or lupus) and healthy controls. **You may be eligible if...** - You are a woman between 18 and 50 years old - You weigh at least 50 kg - You either: have been diagnosed with migraine (at least 4 headache days per month) OR have been diagnosed with an autoimmune or inflammatory condition such as multiple sclerosis, lupus, rheumatoid arthritis, Crohn's disease, Type 1 diabetes, or endometriosis **You may NOT be eligible if...** - Your BMI is below 17 or 30 and above - You have Type 2 diabetes or another chronic autoimmune disease not listed - You are pregnant, recently gave birth, or are breastfeeding - You are going through menopause or have had a hysterectomy or removal of both ovaries - You take hormone therapy (other than contraception or endometriosis treatment) - You have had a bone marrow or organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBlood test

1 blood test of maximum 40 millilitres per patient


Locations(1)

CHU de Clermont-Ferrand - Service de Neurologie

Clermont-Ferrand, AURA, France

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NCT06426316


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