MigraineNCT05112289
A Study to Evaluate White Matter Hyperintensities in Migraine
A study testing Brain Neuroimaging in people with Migraine and Small Vessel Ischemic Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines Read more about this study
- Who is it for?
- Ages 20 to 59 years, women only
- Conditions the study is for
- Migraine, Small Vessel Ischemic Disease, Multiple Sclerosis
- What is being tested?
- Brain Neuroimaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 3 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female only.
- Ages 20-45 years.
- Presence of WMH on MRI.
- Female only
- Ages > 60 years.
- Presence of WMH on MRI.
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- Female only.
- Ages 20-45.
- Presence of WMH on MRI.
Who cannot join
- History of SVI and/or history of MS or other neurological disease other than migraine.
- History of cancer or organ transplantation.
- Contraindication to MRI.
- Pregnancy.
- History of abnormal brain MRI other than WMH.
- Subjects not willing to comply with the study procedures will be removed from the study.
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- History of migraine and/or history of MS or other neurological disease other than SVI.
- History of cancer or organ transplantation.
- History of abnormal brain MRI other than WMH.
- Pregnancy.
- History of abnormal brain MRI other than WMH.
- Subjects not willing to comply with the study procedures will be removed from the study.
- History of migraine and/or history of SVI or other neurological disease other than MS.
- History of cancer or organ transplantation.
- History of abnormal brain MRI other than WMH.
- Pregnancy.
- History of abnormal brain MRI other than WMH.
- Subjects not willing to comply with the study procedures will be removed from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology
The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines
- Conditions
- Migraine, Small Vessel Ischemic Disease, Multiple Sclerosis
- Being tested
- Brain Neuroimaging
- Medical subject headings
- Migraine Disorders, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain NeuroimagingDiagnostic test
Non-invasive magnetic resonance imaging sequences will investigate metabolic signatures unique to migraine WMH. Imaging data will be used for development of artificial intelligence (AI) algorithms to classify the cause of WMHs.
| Study group | Role | What they receive |
|---|---|---|
| Migraine cohort | Other | Women with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. Receives: Diagnostic Test: Brain Neuroimaging |
| Small vessel ischemic (SVI) disease cohort | Other | Women diagnosed with SVI disease and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. Receives: Diagnostic Test: Brain Neuroimaging |
| Multiple sclerosis (MS) cohort | Other | Women diagnosed with MS and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. Receives: Diagnostic Test: Brain Neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
WMH imaging disease parameters
Radiological MRI assessment of WMH in migraine
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start16 Aug 2021
- Primary completion3 Sep 2028 (estimated)
- Study completion3 Sep 2028 (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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine (Cat) Chong, Mayo Clinic
- Investigators
- Catherine Chong, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112289
- Sponsor's protocol ID
- 21-006203
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2021
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology
- ClinicalTrials.gov ID
- NCT05112289
- Acronym / sponsor ID
- 21-006203
- Conditions
- Migraine, Small Vessel Ischemic Disease, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 3 Sep 2028 (estimated)
- Study completion
- 3 Sep 2028 (estimated)
- First posted
- 8 Nov 2021 (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.
The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Migraine cohort | Other | Diagnostic Test: Brain NeuroimagingWomen with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. |
| Small vessel ischemic (SVI) disease cohort | Other | Diagnostic Test: Brain NeuroimagingWomen diagnosed with SVI disease and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. |
| Multiple sclerosis (MS) cohort | Other | Diagnostic Test: Brain NeuroimagingWomen diagnosed with MS and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Female only.
- Ages 20-45 years.
- Presence of WMH on MRI.
- Female only
- Ages > 60 years.
Key exclusion criteria (18 listed)
- History of SVI and/or history of MS or other neurological disease other than migraine.
- History of cancer or organ transplantation.
- Contraindication to MRI.
- Pregnancy.
- History of abnormal brain MRI other than WMH.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain NeuroimagingNon-invasive magnetic resonance imaging sequences will investigate metabolic signatures unique to migraine WMH. Imaging data will be used for development of artificial intelligence (AI) algorithms to classify the cause of WMHs. | Diagnostic test | Migraine cohort, Multiple sclerosis (MS) cohort, Small vessel ischemic (SVI) disease cohort |
Primary outcome
WMH imaging disease parameters
Time frame: 3 months
Radiological MRI assessment of WMH in migraine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- 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.
Catherine Chong, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Neuroimaging in people with Migraine and Small Vessel Ischemic Disease, run by Mayo Clinic at 1 site in United States.
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 9 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WMH imaging disease parameters (time frame: 3 months). 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 24 Sep 2026.