An observational study in Migraine, sponsored by University Medicine Greifswald. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by University Medicine Greifswald · Observational
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 20 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited through the outpatient headache department and through public adverstisement. Patients are consecutively recruited and inclusion/exclusion criteria are minimzied to avoid selection bias.
Exclusion Criteria:
Patients suffering from migraine based on ICHD-3 criteria
Diagnostic Test: Nociceptive Blink Reflex
Patients free of headaches or not suffering from headaches with a frequency that exceeds 1x/year
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
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
Time frame: cross-sectional, once after stimulation
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
Time frame: cross-sectional, once after stimulation
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
Time frame: cross-sectional, once before stimulation
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
Time frame: cross-sectional, once before stimulation
Plan to share: No — IPD can be shared upon reasonable request. Data protection regulation preclude public sharing of data.
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University Medicine Greifswald