Longitudinal Changes of Brain Functional Connectivity in Migraine

The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine

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.

Study Overview

• Status: Unknown
• Conditions: Migraine
• Intervention / Treatment: Diagnostic test: resting-state functional MRI

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Controls and migraineurs who visited to a single university hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Migraineurs; Patients diagnosed with migraine based on the ICHD-3 beta will undergo 3-tesla resting-state functional MRI.	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.
Control; Normal controls without headaches will undergo 3-tesla resting-state functional MRI.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Candidate fMRI features for migraine	Using baseline resting-state fMRI, altered brain networks associated with migraine will be identified by independent component analysis (ICA) between patients and controls.	Baseline (1st year)
Dynamic fMRI features for disease severity	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.	1-year follow-up (2nd year)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: National Research Foundation of Korea; Sungkyunkwan University
• Investigators: Principal Investigator: Mi Ji Lee, MD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 2017-03-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No