About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Females
18 to 50 years old
Chronic migraine participants : chronic migraine (at least 15 days of headache/month, according to the International Classification of Headache Disorders, 3rd edition criteria
Disqualifiers
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 < or = 4 days per month (i.e.: cluster headache, post-traumatic headache, cerebral tumour…)
Pregnancy, delivery, miscarriage, breastfeeding, participation in a medically assisted human reproduction program (ovary stimulation/hormone therapy) < 3 months before blood sampling
Trial design
Parallel
Treatments tested in this trial
Blood sampling, questionnaire and phone call
Biological/VaccineThe blood sample will drawn after a fasting period of at least 8 hours, and the questionnaire will be auto-administered
Treatment groups
Trial outcomes
Primary outcomes
Treg cell suppressive functions
To measure the suppressive effect of Treg cells on Teff cells in chronic migraine patients and healthy controls
Secondary outcomes
CD39+ Treg cell suppressive functions
To measure the suppressive effect of CD39+Treg cells on Teff cells in chronic migraine patients and healthy controls
CD39 activity
To measure the hydrolytic activity of Treg enzyme CD39 in chronic migraine patients and healthy controls
Cytokines
To measure the levels of cytokine levels in blood : interleukin (IL)-6, IL-10, IL-17, IFN-g and transforming growth factor b
Sponsors and contacts
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