Investigating brain features in women with migraine

Investigation of Functional Brain Features in Women with Migraine

This study is testing how the brains of women with menstrual migraines change before and during their headaches compared to women without migraines.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Danish Headache Center (Academic / other)
• Locations: 1 site (Glostrup Municipality)
• Trial ID: NCT06470958 on ClinicalTrials.gov

What this trial studies

This study aims to explore functional brain alterations in women experiencing menstrually-related migraines, focusing on changes that may occur before peripheral vascular changes. Using daily functional MRI scans, the research will monitor participants 2-3 days prior to menstrual bleeding and continue through the headache phase of the migraine. A control group of women without migraines will also undergo the same imaging protocol to compare results. This approach allows for a controlled investigation of spontaneous migraine attacks, which are typically challenging to study.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-40 with episodic menstrually-related migraines who meet specific inclusion criteria.

Not a fit: Patients with other primary headache disorders, secondary headache disorders, or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of migraine mechanisms and lead to improved treatment strategies for women suffering from migraines.

How similar studies have performed: While the specific approach of using functional MRI in this context may be novel, similar studies have shown promise in understanding migraine mechanisms through neuroimaging.

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
* 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

Where this trial is running

Glostrup Municipality

• Danish Headache Center — Glostrup Municipality, Denmark (Recruiting)

Study contacts

• Principal investigator: Faisal Mohammad Amin — Danish Headache Center
• Study coordinator: Faisal Mohammad Amin

Conditions Migraine