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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768828
• Other study ID #: BB 040/22
• Status: Recruiting
• Start date: February 20, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: March 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2023
• Est. primary completion date: May 30, 2023
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of Calcitonin Gene-Related Peptide	Plasma levels of Calcitonin Gene-Related Peptide from samples taken from the cubital vein following nociceptive trigeminal stimulation	cross-sectional, once after stimulation
Secondary	Lacrimal fluid levels of Calcitonin Gene-Related Peptide	Lacrimal fluid levels of Calcitonin Gene-Related Peptide from samples taken from the outer angle of the eye following nociceptive trigeminal stimulation	cross-sectional, once after stimulation
Secondary	Habituation of the nociceptive blink reflex in correlation with plasma levels of Calcitonin Gene-Related Peptide	Explore the correlation of the amplitude of the R2 component of the nociceptive blink reflex with baseline plasma levels of Calcitonin Gene-Related Peptide	cross-sectional, once before stimulation
Secondary	Habituation of the nociceptive blink reflex in correlation with lacrimal fluid levels of Calcitonin Gene-Related Peptide	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	cross-sectional, once before stimulation