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RECRUITING Not applicable ClinicalTrials.gov

Suppressive Functions of Regulatory T Cells in Migraine

Sponsor: University Hospital, Clermont-Ferrand • ClinicalTrials.gov ID: NCT07067112

Registry updated: 2026-10-14
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Description

Migraine is a frequent, disabling condition, of great social and economical impact worldwide. This condition is more frequent in women and subjects with autoimmune and/or inflammatory diseases. Cytokine and immune cell dysregulations have been evidenced in migraine. Inflammation seems to play an important role in migraine chronification; however, the inflammatory mechanisms involved in migraine pathophysiology remain unclear. Regulatory T (Treg) cells play a central role in maintaining immune homeostasis. They regulate effector T (Teff) cell proliferation and cytokine production, through several suppressive mechanisms, such as the hydrolysis of adenosine triphosphate (ATP) into adenosine (ADO), mediated by surface enzymes Cluster Differentiation 39 (CD39) and Cluster Differentiation 73 (CD73). ATP is involved in pain processes in migraine, and insufficient hydrolysis could participate in pain chronification. Recent studies suggest altered proportions of Treg cells in migraine, and decreased levels of CD39-positive (CD39+) Treg cells, suggesting Treg suppressive functions may be decreased in the disease. However, there have been no functional studies to date to confirm this hypothesis. The investigators believe Treg suppressive functions may be decreased in migraine, and that such alterations may be caused by a malfunction in the ADO pathway.

Interventions

  • Blood sampling, questionnaire and phone call (Biological)
    The blood sample will drawn outside of a migraine attack (no migraine within 6 hours prior to the blood test), and the questionnaire will be auto-administered

Eligibility criteria

Inclusion Criteria: * Females * 18 to 50 years old * For chronic migrain : At least 8 monthly migraine days Exclusion Criteria: * BMI \< or = 17kg/m² or \> or = 30kg/m² * Diagnosis or suspicion of type 2 diabetes, auto-immune or inflammatory diseases, immunodeficiency diseases * Diagnosis of headache of non-migraine origin, except for tension type headache (i.e.: cluster headache, post-traumatic headache, cerebral tumour…) * For controls participants : tension type headache with 4 or more monthly headache days * Pregnancy, delivery, miscarriage, breastfeeding, participation in a medically assisted human reproduction program (ovary stimulation/hormone therapy) \< 3 months before blood sampling * Menopause, hysterectomy, or bilateral oophorectomy * Modification of prophylactic anti-migraine therapy (start, change of molecule, interruption) \< 1 month before blood sampling (for migraine participants) * Hormone therapy (beside contraception and treatment of endometriosis) * Transplantation (solid organ or bone marrow) * Cancer (active or remitting) \< 1 year before blood sampling (solid organ or blood) * Haematologic disease (benign or malignant) of the lymphoid lineage * Guardianship, curatorship, safeguard of justice or deprivation of liberty * For controls : history of migraine

Conditions

Chronic Migraine

Locations

  • CHU Clermont-Ferrand — Clermont-Ferrand, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record