Longitudinal Changes of Brain Functional Connectivity in Migraine

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Diagnostic Test: resting-state functional MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migrainuers : age 18-50 years migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta) if female, before the onset of menopausal Controls: age 18-50 years no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta Exclusion criteria: contraindicated to MRI pregnancy require sedation treatment because of claustrophobia when performing MRI predicted to be unable to write the headache diary due to cognitive decline refuse study procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Migraineurs<br>Patients diagnosed with migraine based on the ICHD-3 beta will undergo 3-tesla resting-state functional MRI. | Diagnostic Test: resting-state functional MRI<br>* 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.<br>|
| Control<br>Normal controls without headaches will undergo 3-tesla resting-state functional MRI. | Diagnostic Test: resting-state functional MRI<br>* 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.<br>|

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) |