MigraineNCT06470958
Investigation of Functional Brain Features in Women with Migraine
An observational study of Migraine, run by Danish Headache Center at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Apr 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with menstrually-related migraine and women with no history of migraine. All participants have regular menstruation and 18-40 years old.
Who may be able to join
- 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
Who cannot join
- 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
Show all 44Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Glostrup Municipality
Faisal Mohammad Amin, faisal@dadlnet.dk
About this study
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.
Read the 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.
- Conditions
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Menstrual-related migraine without aura | Migraine patients | |
| Healthy volunteers | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 days in relation to menstruation
Secondary outcomes (4)
Migraine attacks during the menstrual period
Investigate features of migraine attacks during the menstrual period using a headache questionnaire
Measured: Up to 7 days in relation to menstruation
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.
Measured: Up to 5 days in relation to menstruation
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.
Measured: Up to 5 days in relation to menstruation
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.
Measured: Up to 5 days in relation to menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start10 Apr 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Mohammad Amin, Danish Headache Center
- Investigators
- Faisal Mohammad Amin, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470958
- Sponsor's protocol ID
- H-23054319
- Status last verified
- Jun 2024
- First submitted
- 28 Feb 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Functional Brain Features in Women with Migraine
- ClinicalTrials.gov ID
- NCT06470958
- Acronym / sponsor ID
- H-23054319
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menstrual-related migraine without aura | – | –Migraine patients |
| Healthy volunteers | – | –Control group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with menstrually-related migraine and women with no history of migraine. All participants have regular menstruation and 18-40 years old.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (44 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Migraine attacks during the menstrual period
Time frame: Up to 7 days in relation to menstruation
Association of the migraine attack features to brain excitability
Time frame: Up to 5 days in relation to menstruation
Association of the migraine attack features to functional connectivity
Time frame: Up to 5 days in relation to menstruation
Association of the migraine attack features to vasculature changes
Time frame: Up to 5 days in relation to menstruation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faisal Mohammad Amin principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faisal Mohammad Amin (+45 20 85 67 26, faisal@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain excitability in migraine patients (time frame: Up to 5 days in relation to menstruation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.