Investigation of Functional Brain Features in Women with Migraine
ConditionMigraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorDanish Headache Center
About this trial
This study aims to investigate whether the functional alterations in the brain of individuals with migraine appear before the peripheral vascular changes. This will be investigated using functional and structural neuroimaging in individuals with spontaneous menstually-related migraine.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18-40 years of age
Weight 50-100 kg
Regular menstruation
Disqualifiers
Other primary headache disorders than migraine, except infrequent episodic tension-type headache according to the ICHD-3 criteria
Secondary headache disorders
Headache on the first scan day or 48 hours before the first scan
Absence of the menstruation for the past 12 months
Trial population
Women with menstrually-related migraine and women with no history of migraine. All participants have regular menstruation and 18-40 years old.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Menstrual-related migraine without aura
Group B: Healthy volunteers
Trial outcomes
Primary outcomes
1
Brain excitability in migraine patients
Changes in the migraine brain excitability in areas related to migraine during the menstrual period. This will be assessed functional magnetic resonance imaging.
Time frame
Up to 5 days in relation to menstruation2
Brain connectivity in migraine patients
Changes in the migraine brain connectivity in areas related to migraine during the menstrual period. This will be assessed functional magnetic resonance imaging.
Time frame
Up to 5 days in relation to menstruation3
Arterial circumference in migraine patients
Changes in arterial circumference during the menstrual period. This will assessed using Magnetic Resonance Angiography.
Time frame
Up to 5 days in relation to menstruation4
Arterial circumference after rescue medication in migraine patients
Changes in arterial circumference after rescue medication in migraine patients. This will assessed using Magnetic Resonance Angiography.
Time frame
Up to 5 days in relation to menstruationSecondary outcomes
1
Migraine attacks during the menstrual period
Investigate features of migraine attacks during the menstrual period using a headache questionnaire
Time frame
Up to 7 days in relation to menstruation2
Association of the migraine attack features to brain excitability
Investigate the association of the migraine attack features to alterations in the brain excitability during the menstrual period. Functional magnetic resonance imaging and headache questionnaire will be used.
Time frame
Up to 5 days in relation to menstruation3
Association of the migraine attack features to functional connectivity
Investigate the association of the migraine attack features to alterations in the brain functional connectivity during the menstrual period. Functional magnetic resonance imaging and headache questionnaire will be used.
Time frame
Up to 5 days in relation to menstruation4
Association of the migraine attack features to vasculature changes
Investigate the association of the migraine attack features to alterations in the arterial circumference. Magnetic Resonance Angiography and headache questionnaire will be used.
Time frame
Up to 5 days in relation to menstruationSponsors and contacts
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Source ClinicalTrials.gov