Migraine Clinical Trial
Official title:
The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine
Verified date | March 2020 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to identify a core fMRI feature that determines migrainous brain and plastic fMRI features that changes with longitudinal courses of migraine.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: Migrainuers : 1. age 18-50 years 2. migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta) 3. if female, before the onset of menopausal Controls: 1. age 18-50 years 2. no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta Exclusion criteria: 1. contraindicated to MRI 2. pregnancy 3. require sedation treatment because of claustrophobia when performing MRI 4. predicted to be unable to write the headache diary due to cognitive decline 5. refuse study procedure |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center | National Research Foundation of Korea, Sungkyunkwan University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Core fMRI features for migraine brain | Among significant networks identified by ICA, we will identify altered networks which remain unchanged in follow-up resting-state fMRI in 1 year. | 1-year follow-up (2nd year) | |
Secondary | Candidate fMRI features for migraine | Using baseline resting-state fMRI, altered brain networks associated with migraine will be identified by independent component analysis (ICA) between patients and controls. | Baseline (1st year) | |
Secondary | Dynamic fMRI features for disease severity | Among significant networks identified by ICA, we will identify altered networks which change in association with changes in headache frequency in follow-up resting-state fMRI in 1 year. | 1-year follow-up (2nd year) |
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