Suppressive Functions of Regulatory T Cells in Migraine

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity Hospital, Clermont-Ferrand

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Blood sampling, questionnaire and phone call

    Biological/Vaccine

    The blood sample will drawn after a fasting period of at least 8 hours, and the questionnaire will be auto-administered

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Chronic migraineExperimental treatment 1 intervention
Group B: ControlsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treg cell suppressive functions

To measure the suppressive effect of Treg cells on Teff cells in chronic migraine patients and healthy controls

Time frame
Day 0

Secondary outcomes

1

CD39+ Treg cell suppressive functions

To measure the suppressive effect of CD39+Treg cells on Teff cells in chronic migraine patients and healthy controls

Time frame
Day 0
2

CD39 activity

To measure the hydrolytic activity of Treg enzyme CD39 in chronic migraine patients and healthy controls

Time frame
Day 0
3

Cytokines

To measure the levels of cytokine levels in blood : interleukin (IL)-6, IL-10, IL-17, IFN-g and transforming growth factor b

Time frame
Day 0

Other outcomes

Sponsors and contacts

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