Longitudinal Changes of Brain Functional Connectivity in Migraine
The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 24, 2017
CompletedFirst Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedMarch 20, 2020
March 1, 2020
4.6 years
March 27, 2018
March 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Candidate fMRI features for migraine
Baseline (1st year)
Dynamic fMRI features for disease severity
1-year follow-up (2nd year)
Study Arms (2)
Migraineurs
Patients diagnosed with migraine based on the ICHD-3 beta will undergo 3-tesla resting-state functional MRI.
Control
Normal controls without headaches will undergo 3-tesla resting-state functional MRI.
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.
Eligibility Criteria
Controls and migraineurs who visited to a single university hospital
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- National Research Foundation of Koreacollaborator
- Sungkyunkwan Universitycollaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mi Ji Lee, MD
Samsung Medical Center, Sungkyunkwan University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Professor of neurology
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 4, 2018
Study Start
July 24, 2017
Primary Completion
February 28, 2022
Study Completion
February 28, 2023
Last Updated
March 20, 2020
Record last verified: 2020-03