Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.
Study Type
OBSERVATIONAL
Enrollment
242
Patients in PFO occlusion group received PFO closure using devices.
Fuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGResponder rate
Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.
Time frame: From baseline period to 12-month treatment period
Migraine days change per month
Change in the mean number of migraine days from baseline to treatment phase.
Time frame: From baseline period to 12-month treatment period
Number of migraine attacks change per month
Change in the mean number of migraine attacks from baseline to treatment phase.
Time frame: From baseline period to 12-month treatment period
Percentage of complete migraine cessation
Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase.
Time frame: From baseline period to 12-month treatment period
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