Migraine
Conditions
Keywords
migraine, headache, tears, CGRP, PACAP-38, IL-10, IL-1β, TNF-α
Brief summary
The goal of this observational monocentric study is to investigate tear and serum biomarkers in patients with migraine compared with healthy controls, and to explore their potential diagnostic, clinical, and predictive value. In addition to the cross-sectional evaluation, a longitudinal subgroup analysis will be conducted to assess biomarker changes over time during treatment with anti- Calcitonin Gene-Related Peptide (anti-CGRP) therapies.
Interventions
DIAGNOSTIC_TESTPatients with migraine
Patients with migraine
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
patients with migraine * Male or female participants aged ≥ 18 years; * Diagnosis of migraine according to International Classification of Headache Disorders (ICHD) criteria; * Clinical indication, according to routine practice, for treatment with anti-CGRP monoclonal antibodies or gepants (only for the longitudinal subgroup); * Ability and willingness to provide written informed consent. Inclusion criteria for healthy controls * Male or female participants aged ≥ 18 years; * Subjects, without migraine; * Ability and willingness to provide written informed consent.
Exclusion criteria
(for both patients with migraine and healthy controls) * Fulfillment of ICHD diagnostic criteria for secondary headaches; * Active inflammatory ocular diseases; * Severe abnormalities in tear production; * Systemic inflammatory diseases that may interfere with biomarker interpretation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in tear biomarker | Through the study completion, about 3 years | Differences in tear levels between patients with migraine and healthy controls of the following biomarkers: Calcitonin Gene-Related Peptide (CGRP), pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), Interleukin 10 (IL-10), Interleukin 1β (IL-1β), Tumor necrosis factor-α (TNF-α). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlations between tear biomarkers and clinical features of migraine | Through the study completion, about 3 years | * Correlations between tear biomarkers and clinical features of migraine; * Biomarker levels across different migraine phenotypes; * Associations with psychiatric comorbidities and fibromyalgia; * Concordance between tear and plasma levels; longitudinal changes of tear fluid biomarkers during treatment; * Predictive value for treatment response. |
Contacts
CONTACTCatello Vollono, MD, PhD, Neurologist
Outcome results
None listed