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Longitudinal Changes of Brain Functional Connectivity in Migraine

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03487978
Enrollment
100
Registered
2018-04-04
Start date
2017-07-24
Completion date
2023-02-28
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

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.

Interventions

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.

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Sungkyunkwan University
CollaboratorOTHER
Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Core fMRI features for migraine brain1-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

MeasureTime frameDescription
Candidate fMRI features for migraineBaseline (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.
Dynamic fMRI features for disease severity1-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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026