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
|Condition or disease|
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|
|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|
- 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
- structural MRI imaging changes [ Time Frame: 6 months ]changes in cortical thickness of anterior cingulate, amygdala, periquiductal grey, and sensorimotor cortex
- Functional and structural correlates of treatment response [ Time Frame: 6 months ]>50% reduction of monthly headache days
- correlation of functional MRI changes with changes in clinical parameters [ Time Frame: 6 months ]changes in monthly headache days
- responses to acute migraine treatment [ Time Frame: 6 months after the first visit ]the Migraine Assessment of Current Therapy (Migraine-ACT) = 4
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
|Contact: Mi Ji Lee, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Mi Ji Lee, MD 82-2-3410-1895 email@example.com|
|Principal Investigator:||Chin-Sang Chung, MD, PhD||Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine|