Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426316
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-04-30
Brief Title:
The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Immune System Inflammation Migraine - The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIIM
Brief Summary:
Migraine is a frequent and debilitating neurologic disorder It is more frequent in women and more prevalent in patients with autoimmune andor inflammatory diseases such as multiple sclerosis MS rheumatoid arthritis RA Crohns 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 autoimmuneinflammatory disorder MS RA CD SLE T1DM and endometriosis
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 autoimmuneinflammatory disorder MS RA CD SLE T1DM and endometriosis
Detailed Description:
Migraine is the 6th most frequent disease 14 of the population and the second leading cause of disability worldwide From puberty and onward migraine is 2 to 3 times more frequent in women which also suffer from more severe attacks Migraine is also up to twice as prevalent in patients suffering from autoimmune or inflammatory diseases such as multiple sclerosis MS rheumatoid arthritis RA Crohn 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 the identification of the role of peptides such as CGRP in migraine pathophysiology and the development of targetted anti-CGRP treatments many patients remain unresponsive and the mechanisms behind migraine are still unclear
The trigemino-vascular system is involved in the perception of migraine pain Migraine occurs with trigemino-cervical neuron sensitization leading to peptide secretion such as CGRP PACAP-38 and VIP which induce neurogenic inflammation that is responsible for vasodilation capillary leakage oedema and further sensitization of the trigemino-vascular system leading to amplified perception of migraine pain CGRP PACAP-38 and VIP infusions all induce migraine attacks in migraine patients and only mild or no headache in healthy volunteers
Sex hormones prolactin and insulin are also involved in migraine pathophysiology and the immune system through cytokine production and immune cell dysregulations seems to also play a role in the pathogenesis of migraine Both are closely related as sex hormone levels may have an influence on the levels of certain immune cell subtypes Several pro-inflammatory cytokines tumor necrosis factor TNF-alpha interferon IFN-gamma and interleukin IL-6 were shown to be elevated in migraine patients but also inflammatory diseases such as MS and endometriosis compared to controls and are associated with migraine pathophysiology Inflammation seems to be a common factor for migraine and these diseases However these studies provide conflicting results and further investigation is needed to better understand the role of inflammation in migraine pathophysiology
Among T lymphocytes regulatory T Treg cells regulate inflammation by suppressing effector T cells through several suppressive mechanisms such as IL-10 secretion or the hydrolysis of pro-inflammatory and nociceptive adenosine triphosphate ATP into anti-inflammatory and anti-nociceptive adenosine by cluster of differentiation CD 39 and 73 enzymes on the Treg cell surface Recent studies have suggested decreased Treg proportions in migraine patients particularly CD 39 and CD 73-positive Treg cells whereas Treg cells were shown to be increased in T1DM patients This suggests the role of Treg cells in migraine but further studies are needed
In this study the investigators aim to compare Treg levels as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmuneinflammatory disorder MS RA CD SLE T1DM and endometriosis This will provide better understanding of migraine pathophysiology and lead to the development of targeted and personalized treatment strategies according to the immune pain profile and associated inflammatory diseases of migraine patients
Despite the identification of the role of peptides such as CGRP in migraine pathophysiology and the development of targetted anti-CGRP treatments many patients remain unresponsive and the mechanisms behind migraine are still unclear
The trigemino-vascular system is involved in the perception of migraine pain Migraine occurs with trigemino-cervical neuron sensitization leading to peptide secretion such as CGRP PACAP-38 and VIP which induce neurogenic inflammation that is responsible for vasodilation capillary leakage oedema and further sensitization of the trigemino-vascular system leading to amplified perception of migraine pain CGRP PACAP-38 and VIP infusions all induce migraine attacks in migraine patients and only mild or no headache in healthy volunteers
Sex hormones prolactin and insulin are also involved in migraine pathophysiology and the immune system through cytokine production and immune cell dysregulations seems to also play a role in the pathogenesis of migraine Both are closely related as sex hormone levels may have an influence on the levels of certain immune cell subtypes Several pro-inflammatory cytokines tumor necrosis factor TNF-alpha interferon IFN-gamma and interleukin IL-6 were shown to be elevated in migraine patients but also inflammatory diseases such as MS and endometriosis compared to controls and are associated with migraine pathophysiology Inflammation seems to be a common factor for migraine and these diseases However these studies provide conflicting results and further investigation is needed to better understand the role of inflammation in migraine pathophysiology
Among T lymphocytes regulatory T Treg cells regulate inflammation by suppressing effector T cells through several suppressive mechanisms such as IL-10 secretion or the hydrolysis of pro-inflammatory and nociceptive adenosine triphosphate ATP into anti-inflammatory and anti-nociceptive adenosine by cluster of differentiation CD 39 and 73 enzymes on the Treg cell surface Recent studies have suggested decreased Treg proportions in migraine patients particularly CD 39 and CD 73-positive Treg cells whereas Treg cells were shown to be increased in T1DM patients This suggests the role of Treg cells in migraine but further studies are needed
In this study the investigators aim to compare Treg levels as well as identify Treg subpopulations and measure cytokine levels in migraine and migraine-free participants with and without an autoimmuneinflammatory disorder MS RA CD SLE T1DM and endometriosis This will provide better understanding of migraine pathophysiology and lead to the development of targeted and personalized treatment strategies according to the immune pain profile and associated inflammatory diseases of migraine patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01503-42 | OTHER | ANSM | None |