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
Stimulation-evoked Calcitonin Gene-Related Peptide (CGRP) as Biomarker of Migraine
Status
Unknown
Phase
Not applicable
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 14, 2023
Study start
Feb 20, 2023
Primary completion
May 30, 2023
Study completion
Jul 30, 2023
Results posted
Not reported
Registry updated
Mar 14, 2023
Outcomes
What the study measures.
Primary outcomes
Plasma levels of Calcitonin Gene-Related Peptide
Time frame · cross-sectional, once after stimulation
Plasma levels of Calcitonin Gene-Related Peptide from samples taken from the cubital vein following nociceptive trigeminal stimulation
Secondary outcomes
Lacrimal fluid levels of Calcitonin Gene-Related Peptide
Time frame · 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
Time frame · 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
Time frame · 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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Sex
- ALL
- Healthy volunteers
- Not reported
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
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
University Medicine Greifswald
Greifswald, Germany
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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