Longitudinal Changes of Brain Functional Connectivity in Migraine

Sponsor
Samsung Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03487978
Collaborator
National Research Foundation of Korea (Other), Sungkyunkwan University (Other)
100
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67.2
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: resting-state functional MRI

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.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine
Actual Study Start Date :
Jul 24, 2017
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Migraineurs

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

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.

Control

Normal controls without headaches will undergo 3-tesla resting-state functional MRI.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of

Sponsors and Collaborators

  • Samsung Medical Center
  • National Research Foundation of Korea
  • Sungkyunkwan University

Investigators

  • Principal Investigator: Mi Ji Lee, MD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chin-Sang Chung, MD, PhD, Professor of neurology, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03487978
Other Study ID Numbers:
  • 2017-03-113
First Posted:
Apr 4, 2018
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 20, 2020