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Resting-state Functional Connectivity Changes During Migraine Treatment

Resting-state Functional Connectivity Changes During Migraine Treatment: a Structural and Functional MRI Follow-up Study

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03484871
Enrollment
0
Registered
2018-04-02
Start date
2016-05-31
Completion date
2019-04-30
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

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.

Interventions

None listed

Sponsors

SK Chemicals Co., Ltd.
CollaboratorINDUSTRY
Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
functional MRI imaging changes6 monthtemporal 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

MeasureTime frameDescription
Functional and structural correlates of treatment response6 months\>50% reduction of monthly headache days
structural MRI imaging changes6 monthschanges in cortical thickness of anterior cingulate, amygdala, periquiductal grey, and sensorimotor cortex
correlation of functional MRI changes with changes in clinical parameters6 monthschanges in monthly headache days
responses to acute migraine treatment6 months after the first visitthe Migraine Assessment of Current Therapy (Migraine-ACT) = 4

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026