Investigation of Functional Brain Features in Women with Migraine

Danish Headache Center

Status

Enrolling

Conditions

Migraine

Study type

Observational

Funder types

Other

Identifiers

NCT06470958

H-23054319

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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
Perimenstrual syndrome
Pregnant or breastfeeding women
Information or clinical signs of:
- Hypertension (systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg)
- Low blood pressure (systolic blood pressure < 100 mm Hg and/or diastolic blood pressure < 50 mm Hg)
Cardiovascular diseases of any kind, including cerebrovascular disease
Diabetes
Unregulated mental illness or substance abuse
Illnesses of any kind deemed incompatible by the examining physician for participation in the study
Contraindications to MRI (including metal in the body or claustrophobia)
Do not want to be informed about unexpected pathological findings on the MRI

For healthy women

History of any primary headache except infrequent episodic tension-type headache according to the ICHD-3 criteria
First degree family history of primary headache disorders except infrequent episodic tension-type headache according to the ICHD-3 criteria (max five days/month)
Secondary headache disorders
Headache during the menstrual period from 2 days before to 2 days after the first menstrual bleeding day
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
Pregnant or breastfeeding women
Perimenstrual syndrome
Information or clinical signs of:
- Hypertension (systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg)
- Low blood pressure (systolic blood pressure <100 mm Hg and/or diastolic blood pressure < 50 mm Hg) Investigation of functional brain features in women with migraine
Cardiovascular diseases of any kind, including cerebrovascular disease.
Diabetes
Unregulated mental illness or substance abuse
Illnesses of any kind deemed incompatible by the examining physician for participation in the study
Contraindications to MRI (including metal in the body or claustrophobia)
Do not want to be informed about unexpected pathological findings on the MRI