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

NCT06426316 | Recruiting

• 2 other identifiers: RBHP 2023 STUCHFIELD2023-A01503-42
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Migraine Disorders; Pain; Cytokines; Regulatory T cell

Outcome Measures

Primary Outcomes (1)

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

  To measure Treg cell levels in migraine and migraine-free participants, with and without autoimmune/inflammatory diseases (MS, RA, CD, SLE, endometriosis, T1DM) using flow cytometry

  Once, at inclusion

Secondary Outcomes (5)

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

  Once, at inclusion

• 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

• 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

Study Arms (4)

Migraine - no autoimmune/inflammatory disease

EXPERIMENTAL

Migraine - no autoimmune/inflammatory disease group

Biological: Blood test

No migraine - no autoimmune/inflammatory disease

EXPERIMENTAL

No migraine - no autoimmune/inflammatory disease group

Biological: Blood test

No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis)

EXPERIMENTAL

No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group

Biological: Blood test

Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis)

EXPERIMENTAL

Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis) group

Biological: Blood test

Interventions

Blood test BIOLOGICAL

1 blood test of maximum 40 millilitres per patient

Migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis); Migraine - no autoimmune/inflammatory disease; No migraine - autoimmune/inflammatory disease (MS, RA, CD, SLE, T1DM, endometriosis); No migraine - no autoimmune/inflammatory disease

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand - Service de Neurologie

Clermont-Ferrand, AURA, 63000, France

RECRUITING

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MeSH Terms

Conditions

Migraine Disorders; Pain; Autoimmune Diseases; Multiple Sclerosis; Endometriosis; Arthritis, Rheumatoid; Crohn Disease

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Xavier MOISSET

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 23, 2024
• Study Start: June 2, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-06

Locations

FR (1)