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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05768828
Other study ID # BB 040/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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