Longitudinal Changes of Brain Functional Connectivity in Migraine

Overview

The purpose of this study is to identify a core fMRI feature that determines migrainous brain and plastic fMRI features that changes with longitudinal courses of migraine.

Full Title of Study: “The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 28, 2022

Detailed Description

Migraine is associated with functional alterations in specific brain networks. The investigators aimed to identify network abnormalities which remain unchanged throughout the longitudinal course of migraine. The investigators also aimed to identify networks which change in association with changes in migraine frequency and associated psychiatric conditions. The investigators expect these can serve as neuroimaging biomarkers for diagnosis of migraine brain and monitoring of disease severity.

Interventions

  • Diagnostic Test: resting-state functional MRI
    • To ensure inter-ictal fMRI, confirm that the subject has no migraine for at least 48 hours before the procedure. Record the time difference between the date on the day of fMRI and the date of the last headache attack and record whether the headache on the day of fMRI is absent or not. On the third day after MRI, examine whether the subject has headache or not.

Arms, Groups and Cohorts

  • Migraineurs
    • Patients diagnosed with migraine based on the ICHD-3 beta will undergo 3-tesla resting-state functional MRI.
  • Control
    • Normal controls without headaches will undergo 3-tesla resting-state functional MRI.

Clinical Trial Outcome Measures

Primary Measures

  • Core fMRI features for migraine brain
    • Time Frame: 1-year follow-up (2nd year)
    • Among significant networks identified by ICA, we will identify altered networks which remain unchanged in follow-up resting-state fMRI in 1 year.

Secondary Measures

  • Candidate fMRI features for migraine
    • Time Frame: Baseline (1st year)
    • Using baseline resting-state fMRI, altered brain networks associated with migraine will be identified by independent component analysis (ICA) between patients and controls.
  • Dynamic fMRI features for disease severity
    • Time Frame: 1-year follow-up (2nd year)
    • Among significant networks identified by ICA, we will identify altered networks which change in association with changes in headache frequency in follow-up resting-state fMRI in 1 year.

Participating in This Clinical Trial

Inclusion Criteria

Migrainuers : 1. age 18-50 years 2. migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta) 3. if female, before the onset of menopausal Controls: 1. age 18-50 years 2. no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta Exclusion criteria:

1. contraindicated to MRI 2. pregnancy 3. require sedation treatment because of claustrophobia when performing MRI 4. predicted to be unable to write the headache diary due to cognitive decline 5. refuse study procedure

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Collaborator
    • National Research Foundation of Korea
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chin-Sang Chung, MD, PhD, Professor of neurology – Samsung Medical Center
  • Overall Official(s)
    • Mi Ji Lee, MD, Principal Investigator, Samsung Medical Center, Sungkyunkwan University School of Medicine

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