Status:
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 Criteria:
- 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 Criteria:
- Patients with a history of PFO closure or other migraine-related surgical treatments;
- Patients with other severe cardiac or neurological diseases, mental disorders, or psychological conditions;
- Patients with contraindications to closure surgery or MRI scans (e.g., severe infection, coagulation dysfunction, cardiac pacemakers, aneurysm clips, metallic foreign bodies in the eye, non-removable metal dentures, etc.);
- Patients unable to complete migraine symptom assessments or imaging examinations due to other reasons.
Key Trial Info
Start Date :
January 14 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07170176
Start Date
January 14 2026
End Date
December 31 2027
Last Update
January 16 2026
Active Locations (2)
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1
Luoyang Central Hospital
Luoyang, Henan, China, 471009
2
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211