Investigation of Functional Brain Features in Women with Migraine

NCT06470958 | Recruiting

• 1 other identifier: H-23054319
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (7)

• 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.

  Up to 5 days in relation to menstruation

• 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.

  Up to 5 days in relation to menstruation

• Arterial circumference in migraine patients

  Changes in arterial circumference during the menstrual period. This 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. This will assessed using Magnetic Resonance Angiography.

  Up to 5 days in relation to menstruation

• Brain excitability in healthy volunteers

  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.

  Up to 5 days in relation to menstruation

• Brain connectivity in healthy volunteers

  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.

  Up to 5 days in relation to menstruation

• Arterial circumference in healthy volunteers

  Changes in arterial circumference during the menstrual period in healthy volunteers. This will assessed using Magnetic Resonance Angiography.

  Up to 5 days in relation to menstruation

Secondary Outcomes (4)

• 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

Study Arms (2)

Menstrual-related migraine without aura

Migraine patients

Healthy volunteers

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with menstrually-related migraine and women with no history of migraine. All participants have regular menstruation and 18-40 years old.

You may qualify if:

• 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
• years of age
• Weight 50-100 kg
• Regular menstruation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, Denmark

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Faisal Mohammad Amin

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faisal Mohammad Amin

CONTACT

+45 20 85 67 26; faisal@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: June 24, 2024
• Study Start: April 10, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)