Longitudinal Changes of Brain Functional Connectivity in Migraine

NCT ID: NCT03487978

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2023-02-28

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.

Conditions

Migraine

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Migraineurs

Patients diagnosed with migraine based on the ICHD-3 beta will undergo 3-tesla resting-state functional MRI.

resting-state functional MRI

Intervention Type: DIAGNOSTIC_TEST

1. To ensure inter-ictal fMRI, confirm that the subject has no migraine for at least 48 hours before the procedure.

2. 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.

3. 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.

resting-state functional MRI

Intervention Type: DIAGNOSTIC_TEST

1. To ensure inter-ictal fMRI, confirm that the subject has no migraine for at least 48 hours before the procedure.

2. 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.

3. On the third day after MRI, examine whether the subject has headache or not.

Interventions

resting-state functional MRI

1. To ensure inter-ictal fMRI, confirm that the subject has no migraine for at least 48 hours before the procedure.

2. 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.

3. On the third day after MRI, examine whether the subject has headache or not.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Sungkyunkwan University

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Chin-Sang Chung

MD, PhD, Professor of neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi Ji Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2017-03-113

Identifier Type: -

Identifier Source: org_study_id