Stimulation-evoked Calcitonin Gene-Related Peptide (CGRP) as Biomarker of Migraine

Recruiting

• Conditions: Migraine
• Interventions: Diagnostic Test: Nociceptive Blink Reflex

• Registration Number: NCT05768828
• Lead Sponsor: University Medicine Greifswald

Brief Summary

This study aims to improve the management migraine by providing a more profound understanding of the interactions of pain disinhibition on the brain stem level and calcitonin gene-related peptide as a main mediator in the generation of migraine headaches. For this purpose, this observational study investigates established neurophysiological and blood biomarkers parameters in association with the clinical phenotype.

Detailed Description

The study's focus is the investigation of mechanisms that are directly related to the pain generation in migraine. In this context, the primary endpoint is an enhancement of trigeminal stimulation evoked calcitonin gene-related peptide (CGRP). The stimulation is normalized using an established protocol to elicit the nociceptive blink reflex, which is a brain stem reflex to study the trigemino-spinal system. We expect CGRP levels to rise more in patients affected by migraine as compared to controls, based on the observation that painful stimulation elicits migraine attacks. Furthermore, baseline CGRP levels and their association with markers of brainstem excitability are probed.

Study Timeline

• Study Start: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-05-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Migraine according to ICHD-3 criteria (cases)
• No headaches or tension-type headache frequency <1x/year (controls)

Exclusion Criteria

• other chronic pain disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	Nociceptive Blink Reflex	Patients free of headaches or not suffering from headaches with a frequency that exceeds 1x/year
Migraine	Nociceptive Blink Reflex	Patients suffering from migraine based on ICHD-3 criteria

Primary Outcome Measures

Name	Time	Method
Plasma levels of Calcitonin Gene-Related Peptide	cross-sectional, once after stimulation	Plasma levels of Calcitonin Gene-Related Peptide from samples taken from the cubital vein following nociceptive trigeminal stimulation

Secondary Outcome Measures

Name	Time	Method
Lacrimal fluid levels of Calcitonin Gene-Related Peptide	cross-sectional, once after stimulation	Lacrimal fluid levels of Calcitonin Gene-Related Peptide from samples taken from the outer angle of the eye following nociceptive trigeminal stimulation
Habituation of the nociceptive blink reflex in correlation with plasma levels of Calcitonin Gene-Related Peptide	cross-sectional, once before stimulation	Explore the correlation of the amplitude of the R2 component of the nociceptive blink reflex with baseline plasma levels of Calcitonin Gene-Related Peptide
Habituation of the nociceptive blink reflex in correlation with lacrimal fluid levels of Calcitonin Gene-Related Peptide	cross-sectional, once before stimulation	Explore the correlation of the amplitude of the R2 component of the nociceptive blink reflex with baseline lacrimal fluid levels of Calcitonin Gene-Related Peptide

Trial Locations

Locations (1)

University Medicine Greifswald; 🇩🇪 Greifswald, Germany