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

RecruitingNot a drug-phase studyMS (type not specified)NCT06426316

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Blood test

What it measured

Main measures

  • Treg cell levels in cell/microliter (cell/µL) and percentage (%) of white blood cells

    Once, at inclusion

Other measures (5)

  • Cytokine levels in picogram per milliliter (pg/mL)

    Once, at inclusion

    Immune response
  • Impact of hormones (progesterone, estrogen, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH), insulin and prolactin) levels on levels of Treg cells

    Once, at inclusion

  • Impact of hormones (progesterone, estrogen, testosterone, follicle stimulating hormone (FSH), luteinizing hormone (LH), insulin and prolactin) levels on levels of cytokines

    Once, at inclusion

    Immune response
  • Impact of neuropeptides (calcitonin gene-related peptide (CGRP), vasoactive intestinal polypeptide (VIP), pituitary adenylate cyclase-activating polypeptide (PACAP) on Treg cell levels

    Once, at inclusion

  • Impact of neuropeptides (calcitonin gene-related peptide (CGRP), vasoactive intestinal polypeptide (VIP), pituitary adenylate cyclase-activating polypeptide (PACAP) on cytokine levels

    Once, at inclusion

    Immune response

Who could take part

MS (type not specified) · 18 to 50

Show the full criteria

Inclusion criteria

* female * 18 - 50 years of age * at least 50 kg * autoimmune/inflammatory disease groups : with a diagnosis of multiple sclerosis, systemic lupus erythematous, rheumatoid arthritis, Crohn's disease, type 1 diabetes or endometriosis * migraine group : with a diagnosis of migraine with at least 4 headache days per month

Exclusion criteria

* BMI \< or = 17 ou > or = 30kg/m² * type 2 diabetes, immune deficit, other chronic autoimmune or inflammatory disease * non-migraine headache, except for tension type headache of less than 4 days/month * pregnancy, delivery, miscarriage, breast-feeding, participation in a medically assisted human reproduction program (ovary stimulation/hormone therapy) \< 3 months before blood sampling * Menopause, hysterectomy, or bilateral oophorectomy * Hormone therapy (besides contraception and treatment of endometriosis) * bone marrow or solid organ transplant * guardianship, curatorship, safeguard of justice or deprivation of liberty * for patients : diagnosis of several autoimmune or inflammatory diseases * for controls : diagnosis of an autoimmune or inflammatory disease * for non-migraine participants : migraine

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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).

Papers

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History

    1. Started

      Jun 2025

    2. Main results due

      Apr 2027

    3. Finished

      Apr 2027

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