Investigation of Functional Brain Features in Women With Migraine
NCT Number: NCT06470958
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Migraine
Sponsor: Danish Headache Center
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-04-10
Completion Date: 2026-01-31
Locations: Danish Headache Center, Glostrup, Denmark

Summary:
The goal of this study is to learn about

Spontaneous migraine attacks are unpredictable and have therefore been logistically very challenging and arduous to investigate in neuroimaging studies. Thus, menstrually-related migraine provides an opportunity to study spontaneous attacks in a controlled imaging setup. The present project aims to investigate women with menstrually-related migraine using daily functional magnetic resonance imaging (MRI) scans 2-3 days before the onset of the menstrual bleeding and until (and including) the headache phase of migraine or up to five consecutive days. A control-group of women without migraine will also be recruited and undergo the same MRI scan protocol.

Primary Outcome Measures: Brain excitability and connectivity in migraine patients, Changes in the migraine brain excitability and connectivity in areas related to migraine during the menstrual period. The brain excitability and connectivity will be assessed using Functional magnetic resonance imaging., Up to 5 days in relation to menstruation|Arterial circumference in migraine patients, Changes in arterial circumference during the menstrual period. The arterial circumference will assessed using Magnetic Resonance Angiography., Up to 5 days in relation to menstruation|Arterial circumference after rescue medication in migraine patients, Changes in arterial circumference after rescue medication in migraine patients. The arterial circumference will assessed using Magnetic Resonance Angiography., Up to 5 days in relation to menstruation|Brain excitability or connectivity after rescue medication in migraine patients, Changes in migraine brain excitability after rescue medication in migraine patients. The brain excitability and connectivity will be assessed using Functional magnetic resonance imaging., Up to 5 days in relation to menstruation|Brain excitability or connectivity in healthy volunteers, Changes in brain excitability or connectivity in areas related to migraine during the menstrual period in healthy volunteers. The brain excitability and connectivity will be assessed using Functional magnetic resonance imaging., Up to 5 days in relation to menstruation|Arterial circumference in healthy volunteers, Changes in arterial circumference during the menstrual period in healthy volunteers. The arterial circumference will assessed using Magnetic Resonance Angiography., Up to 5 days in relation to menstruation
Secondary Outcome Measures: Migraine attacks during the menstrual period, Investigate features of migraine attacks during the menstrual period using a headache questionnaire, Up to 5 days in relation to menstruation|Association of the migraine attack features to brain excitability and functional connectivity, Investigate the association of the migraine attack features to alterations in the brain excitability and functional connectivity. e during the menstrual period in healthy volunteers. The brain excitability and connectivity will be assessed using Functional magnetic resonance imaging., Up to 5 days in relation to menstruation|Association of the migraine attack features to vasculature, Investigate the association of the migraine attack features to alterations in the arterial circumference. The arterial circumference will assessed using Magnetic Resonance Angiography., Up to 5 days in relation to menstruation