Migraine
Conditions
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.
Interventions
DIAGNOSTIC_TESTNociceptive 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
Sponsors
University Medicine Greifswald
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed