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A Study to Evaluate White Matter Hyperintensities in Migraine

Primary Purpose

Migraine, Small Vessel Ischemic Disease, Multiple Sclerosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Neuroimaging
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Migraine

Eligibility Criteria

20 Years - 59 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Mayo Clinic in Arizona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Migraine cohort

Small vessel ischemic (SVI) disease cohort

Multiple sclerosis (MS) cohort

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

WMH imaging disease parameters
Radiological MRI assessment of WMH in migraine

Secondary Outcome Measures

Full Information

First Posted
October 12, 2021
Last Updated
September 17, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05112289
Brief Title
A Study to Evaluate White Matter Hyperintensities in Migraine
Official Title
White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Small Vessel Ischemic Disease, Multiple Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Migraine cohort
Arm Type
Other
Arm Description
Women with migraine and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Arm Title
Small vessel ischemic (SVI) disease cohort
Arm Type
Other
Arm Description
Women diagnosed with SVI disease and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Arm Title
Multiple sclerosis (MS) cohort
Arm Type
Other
Arm Description
Women diagnosed with MS and presence of white matter hyperintensities (WMH) on clinical magnetic resonance imaging (MRI) will have brain neuroimaging.
Intervention Type
Diagnostic Test
Intervention Name(s)
Brain Neuroimaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
WMH imaging disease parameters
Description
Radiological MRI assessment of WMH in migraine
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Chong, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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A Study to Evaluate White Matter Hyperintensities in Migraine

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