Investigation of Functional Brain Features in Women with Migraine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- Danish Headache Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Brain excitability in migraine patients
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Spontaneous migraine attacks are unpredictable and therefore been logistically arduous to investigate in neuroimaging studies. 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.
Investigators
Faisal Mohammad Amin
Principal Investigator
Danish Headache Center
Eligibility Criteria
Inclusion Criteria
- •For women with migraine
- •Episodic menstrually-related migraine without aura \> 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
- •For women with migraine and healthy women
- •18-40 years of age
- •Weight 50-100 kg
- •Regular menstruation
Exclusion Criteria
- •For women with migraine
- •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
- •Daily intake of medication of any kind except oral contraceptives
- •Ingestion of any type of medication later than 4 times the plasma half-life of the substance in question (on the day of the scan), except for oral contraceptives
- •Intake of coffee, tea or alcohol 12 hours prior to scan days
- •Fertile women not using safe contraception. Fertile women are defined as women without hysterectomy and \< 2 years postmenopausal women. Safe contraception includes the intrauterine device, oral contraceptive pills, surgical sterilization of the woman, depot progestogen or condoms
- •Change of hormonal contraceptives for the past 3 months
Outcomes
Primary Outcomes
Brain excitability in migraine patients
Time Frame: Up to 5 days in relation to menstruation
Changes in the migraine brain excitability in areas related to migraine during the menstrual period. This will be assessed functional magnetic resonance imaging.
Brain connectivity in migraine patients
Time Frame: Up to 5 days in relation to menstruation
Changes in the migraine brain connectivity in areas related to migraine during the menstrual period. This will be assessed functional magnetic resonance imaging.
Arterial circumference in migraine patients
Time Frame: Up to 5 days in relation to menstruation
Changes in arterial circumference during the menstrual period. This will assessed using Magnetic Resonance Angiography.
Arterial circumference after rescue medication in migraine patients
Time Frame: Up to 5 days in relation to menstruation
Changes in arterial circumference after rescue medication in migraine patients. This will assessed using Magnetic Resonance Angiography.
Brain excitability in healthy volunteers
Time Frame: Up to 5 days in relation to menstruation
Changes in brain excitability or connectivity in areas related to migraine during the menstrual period in healthy volunteers. This will be assessed using functional magnetic resonance imaging.
Brain connectivity in healthy volunteers
Time Frame: Up to 5 days in relation to menstruation
Changes in brain connectivity in areas related to migraine during the menstrual period in healthy volunteers. This will be assessed using functional magnetic resonance imaging.
Arterial circumference in healthy volunteers
Time Frame: Up to 5 days in relation to menstruation
Changes in arterial circumference during the menstrual period in healthy volunteers. This will assessed using Magnetic Resonance Angiography.
Secondary Outcomes
- Migraine attacks during the menstrual period(Up to 7 days in relation to menstruation)
- Association of the migraine attack features to brain excitability(Up to 5 days in relation to menstruation)
- Association of the migraine attack features to functional connectivity(Up to 5 days in relation to menstruation)
- Association of the migraine attack features to vasculature changes(Up to 5 days in relation to menstruation)