Longitudinal Changes of Brain Functional Connectivity in Migraine

• Conditions: Migraine
• Interventions: Diagnostic Test: resting-state functional MRI

• Registration Number: NCT03487978
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-24
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20
• Primary Completion: 2022-02-28
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Core fMRI features for migraine brain	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 Outcome Measures

Name	Time	Method
Dynamic fMRI features for disease severity	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.
Candidate fMRI features for migraine	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of