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Resting-state Functional Connectivity Changes During Migraine Treatment

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ClinicalTrials.gov Identifier: NCT03484871
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Collaborator:
SK Chemicals Co.,Ltd.
Information provided by (Responsible Party):
Chin-Sang Chung, Samsung Medical Center

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
Migraine Disorders

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 Type : Observational
Estimated Enrollment : 30 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 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine




Primary Outcome Measures :
  1. functional MRI imaging changes [ Time Frame: 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 [ Time Frame: 6 months ]
    changes in cortical thickness of anterior cingulate, amygdala, periquiductal grey, and sensorimotor cortex

  2. Functional and structural correlates of treatment response [ Time Frame: 6 months ]
    >50% reduction of monthly headache days

  3. correlation of functional MRI changes with changes in clinical parameters [ Time Frame: 6 months ]
    changes in monthly headache days

  4. responses to acute migraine treatment [ Time Frame: 6 months after the first visit ]
    the Migraine Assessment of Current Therapy (Migraine-ACT) = 4



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with migraine
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484871


Contacts
Contact: Mi Ji Lee, MD 82-2-3410-1895 mirony.lee@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Mi Ji Lee, MD    82-2-3410-1895    mirony.lee@gmail.com   
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

Responsible Party: Chin-Sang Chung, MD, PhD, Professor of neurology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03484871     History of Changes
Other Study ID Numbers: 2016-04-028
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases