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

University Medicine Greifswald

Status: Enrolling

Conditions: Migraine

Treatments: Diagnostic Test: Nociceptive Blink Reflex

Study type: Observational

Funder types: Other

Identifiers

NCT05768828

BB 040/22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Migraine

Description:

Patients suffering from migraine based on ICHD-3 criteria

Treatment:

Diagnostic Test: Nociceptive Blink Reflex

Controls

Description:

Patients free of headaches or not suffering from headaches with a frequency that exceeds 1x/year

Treatment:

Diagnostic Test: Nociceptive Blink Reflex