Resting-state Functional Connectivity Changes During Migraine Treatment

Sponsor
Samsung Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03484871
Collaborator
SK Chemicals Co., Ltd. (Industry)
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1
35
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Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether reduced frequency of migraine attacks are associated with signal alternation and connectivity of cerebral cortex.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients with migraine show reduced cortical thickness in regions subserving pain processing, and it is related to increasing headache frequency. In the past, only one study has shown a reversibility consequence of chronic nociceptive transmission, which normalizes when the pain is adequately treated. However, little is known whether these changes predispose to migraine or represent the effect of repeated migraine attacks. Our region of interest is reduced frequency of migraine attacks are associated with reversibility of signal alternation and functional connectivity of cerebral cortex.

    In 30 migraineurs with 8-14days with headache per months who already performed brain magnetic resonance imaging will be recruited. Treatment medications such as frovatriptan and topiramate will be used for 6 months. After 6 months, follow-up brain magnetic resonance imaging will be performed.

    The primary outcome is the longitudinal changes in functional connectivity in pain-processing/modulating brain regions. The secondary outcome is following: 1)longitudinal changes in structural and morphological alterations in brain regions of pain processing; 2)structural, morphological, and functional correlates of treatment response; 3)changes in monthly migraine days, migraine frequecies, headache days, and headache frequencies after treatment; 4)responses to acute migraine treatment.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Resting-state Functional Connectivity Changes During Migraine Treatment: a Structural and Functional MRI Follow-up Study
    Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Nov 1, 2018
    Actual Study Completion Date :
    Apr 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. functional MRI imaging changes [6 month]

      temporal changes in BOLD correlations in the regions of most significant correlation with periaqueductal grey; temporal changes in BOLD correlations in the regions of most significant correlation with anterior cingulate cortex; temporal changes in default mode network

    Secondary Outcome Measures

    1. structural MRI imaging changes [6 months]

      changes in cortical thickness of anterior cingulate, amygdala, periquiductal grey, and sensorimotor cortex

    2. Functional and structural correlates of treatment response [6 months]

      >50% reduction of monthly headache days

    3. correlation of functional MRI changes with changes in clinical parameters [6 months]

      changes in monthly headache days

    4. responses to acute migraine treatment [6 months after the first visit]

      the Migraine Assessment of Current Therapy (Migraine-ACT) = 4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Premenopausal Women

    • Aged 18-50

    • Drug-naïve high frequency episodic migraineurs (8-14 attacks/m)

    • Performed a baseline interictal brain MRI

    Exclusion Criteria:
    • Medication overuse

    • Chronic pain other than migraine

    • On treatment of major depression, bipolar, schizophrenia, or BDI>25

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Samsung Medical Center
    • SK Chemicals Co., Ltd.

    Investigators

    • Principal Investigator: Chin-Sang Chung, MD, PhD, Department of Neurology, 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:
    NCT03484871
    Other Study ID Numbers:
    • 2016-04-028
    First Posted:
    Apr 2, 2018
    Last Update Posted:
    Mar 20, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 20, 2020