A Study to Evaluate White Matter Hyperintensities in Migraine

Study Overview
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Brief Summary
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The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines

Official Title
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White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology

Conditions
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Migraine, Small Vessel Ischemic Disease, Multiple Sclerosis

Intervention / Treatment
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* Diagnostic Test: Brain Neuroimaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - Migraine (N=20): Female only. Ages 20-45 years. Presence of WMH on MRI. Exclusion Criteria: 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. Inclusion Criteria - SVI disease (n=10): Female only Ages > 60 years. Presence of WMH on MRI. Exclusion Criteria: 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. Inclusion Criteria - MS (n=10): Female only. Ages 20-45. Presence of WMH on MRI. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Migraine cohort<br>Women with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. | Diagnostic Test: Brain Neuroimaging<br>* 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.<br>|
| Other: Small vessel ischemic (SVI) disease cohort<br>Women diagnosed with SVI disease and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. | Diagnostic Test: Brain Neuroimaging<br>* 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.<br>|
| Other: Multiple sclerosis (MS) cohort<br>Women diagnosed with MS and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging. | Diagnostic Test: Brain Neuroimaging<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WMH imaging disease parameters | Radiological MRI assessment of WMH in migraine | 3 months |