Resting-state Functional Connectivity Changes During Migraine Treatment

NCT ID: NCT03484871

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Migraine Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Chin-Sang Chung

MD, PhD, Professor of neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chin-Sang Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2016-04-028

Identifier Type: -

Identifier Source: org_study_id

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