NCT05768828

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

Calcitonin Gene-Related Peptide (CGRP) and Neurophysiological Biomarkers of Migraine

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Nociceptive Blink Reflex	Noxious trigeminal electrical stimulation at different interstimulus intervals using 1.5x the pain threshold in order to provoke a release of trigeminal CGRP

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-05-30
• Completion: 2023-07-30
• First posted: 2023-03-14
• Last updated: 2023-03-14

Locations

1 site across 1 country: Germany