Resting-state Functional Connectivity Changes During Migraine Treatment

Withdrawn

• Conditions: Migraine Disorders

• Registration Number: NCT03484871
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2018-03-25
• Study First Posted: 2018-04-02
• Primary Completion: 2018-11
• Study Completion: 2019-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Premenopausal Women
• Aged 18-50
• Drug-naïve high frequency episodic migraineurs (8-14 attacks/m)
• Performed a baseline interictal brain MRI

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Exclusion Criteria

• Medication overuse
• Chronic pain other than migraine
• On treatment of major depression, bipolar, schizophrenia, or BDI>25

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
structural MRI imaging changes	6 months	changes in cortical thickness of anterior cingulate, amygdala, periquiductal grey, and sensorimotor cortex
Functional and structural correlates of treatment response	6 months	\>50% reduction of monthly headache days
responses to acute migraine treatment	6 months after the first visit	the Migraine Assessment of Current Therapy (Migraine-ACT) = 4
correlation of functional MRI changes with changes in clinical parameters	6 months	changes in monthly headache days

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of