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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with migraine | Patients with migraine |
| |
| Healthy controls | Healthy controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with migraine | Diagnostic Test | Patients with migraine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in tear biomarker | 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). | Through the study completion, about 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Correlations between tear biomarkers and clinical features of migraine |
|
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Inclusion criteria patients with migraine
Exclusion criteria (for both patients with migraine and healthy controls)
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Patients with migraine and healthy controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catello Vollono, MD, PhD, Neurologist | Contact | +393920105407 | catello.vollono@policlinicogemelli.it |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Through the study completion, about 3 years |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |