Status:
NOT_YET_RECRUITING
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Migraine Disorders
Patent Foramen Ovale
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Patent Foramen Ovale (PFO) is a common congenital heart defect. Recent studies have suggested a potential association between PFO and migraines, particularly migraine with aura. It is hypothesized tha...
Eligibility Criteria
Inclusion
- Adults aged 18 to 60 years.
- Diagnosed with patent foramen ovale (PFO) with significant right-to-left shunt.
- For the case group: Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-3).
- For the control group: No history of migraine.
- Willing and able to provide written informed consent.
- Education level of primary school or higher.
Exclusion
- Prior history of PFO closure or other migraine surgery.
- Comorbid with other severe cardiac (e.g., complex congenital heart disease) or neurological diseases.
- Use of medications that may affect migraine symptoms (e.g., prophylactic migraine medications, antidepressants) within the past 3 months.
- Contraindications to the PFO closure procedure (e.g., active infection, coagulation dysfunction).
- Inability to complete migraine symptom assessments or MRI examinations (e.g., claustrophobia, presence of MRI-incompatible implants).
Key Trial Info
Start Date :
December 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07170176
Start Date
December 30 2025
End Date
December 20 2028
Last Update
September 12 2025
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