Clinical trial NCT03484871: Resting-state Functional Connectivity Changes During Migraine Treatment
Official title: Resting-state Functional Connectivity Changes During Migraine Treatment: a Structural and Functional MRI Follow-up Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Migraine Disorders
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: SK Chemicals Co., Ltd.
First posted: 2018-04-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with migraine

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.

Eligibility 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

Primary outcomes:
measure: functional MRI imaging changes
timeFrame: 6 month
Secondary outcomes:
measure: structural MRI imaging changes
timeFrame: 6 months
measure: Functional and structural correlates of treatment response
timeFrame: 6 months
measure: correlation of functional MRI changes with changes in clinical parameters
timeFrame: 6 months
measure: responses to acute migraine treatment
timeFrame: 6 months after the first visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Chin-Sang Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: