A Study to Evaluate White Matter Hyperintensities in Migraine

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05112289

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Migraine Small Vessel Ischemic Disease Multiple Sclerosis	Diagnostic Test: Brain Neuroimaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Aug 16, 2021

Anticipated Primary Completion Date :

Aug 16, 2022

Anticipated Study Completion Date :

Aug 16, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Migraine cohort

Women with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.

Diagnostic Test: Brain Neuroimaging

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.

Other: Small vessel ischemic (SVI) disease cohort

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

Other: Multiple sclerosis (MS) cohort

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

Outcome Measures

Primary Outcome Measures

WMH imaging disease parameters [3 months]
Radiological MRI assessment of WMH in migraine

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 59 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Phoenix	Arizona	United States	85054

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Catherine Chong, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Catherine (Cat) Chong, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05112289

Other Study ID Numbers:

21-006203

First Posted:

Nov 8, 2021

Last Update Posted:

Nov 8, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Migraine Disorders

Study Results

No Results Posted as of Nov 8, 2021