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

Inclusion Criteria5

  • female
  • 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 Criteria11

  • 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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06426316


Related Trials