Longitudinal Changes of Brain Functional Connectivity in Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03487978
• Other study ID #: 2017-03-113
• Status: Active, not recruiting
• Start date: July 24, 2017
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Samsung Medical Center	National Research Foundation of Korea, Sungkyunkwan University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)