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

NCT05768828 | Unknown

• 1 other identifier: BB 040/22
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Lacrimal fluid levels of Calcitonin Gene-Related Peptide

  cross-sectional, once after stimulation

• Habituation of the nociceptive blink reflex in correlation with plasma levels of Calcitonin Gene-Related Peptide

  cross-sectional, once before stimulation

• Habituation of the nociceptive blink reflex in correlation with lacrimal fluid levels of Calcitonin Gene-Related Peptide

  cross-sectional, once before stimulation

Study Arms (2)

Migraine

Patients suffering from migraine based on ICHD-3 criteria

Diagnostic Test: Nociceptive Blink Reflex

Controls

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

Diagnostic Test: Nociceptive Blink Reflex

Interventions

Nociceptive Blink Reflex DIAGNOSTIC_TEST

Noxious trigeminal electrical stimulation at different interstimulus intervals using 1.5x the pain threshold in order to provoke a release of trigeminal CGRP

Controls; Migraine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Migraine according to ICHD-3 criteria (cases)
• No headaches or tension-type headache frequency \<1x/year (controls)

You may not qualify if:

• other chronic pain disorder

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine Greifswald

Greifswald, 17475, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood from cubital vein and lacrimal fluid

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 14, 2023
• Study Start: February 20, 2023
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)