Tests closing a heart hole to see effects on migraine and brain fluid flow
Tests closing a heart opening, called PFO, in adults with migraine.
Plain-language title generated from the registry record
Registry title: Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Key facts
- Where
- Luoyang and Tianjin, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07170176, who can take part
Where in China
- Luoyang Central HospitalLuoyang, ChinaTaking people
- The Second Hospital of Tianjin Medical UniversityTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital Xi'an Jiaotong University
- Trial code
- NCT07170176
- Record updated
- 16 January 2026
- Original description
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 that PFO may allow microemboli or vasoactive substances from venous blood to bypass pulmonary metabolism and enter the arterial system directly, potentially triggering migraines. Although PFO closure has been shown to reduce the frequency and severity of migraine attacks, its long-term efficacy and underlying mechanisms require further investigation.Read full original descriptionShow less
The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
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 that PFO may allow microemboli or vasoactive substances from venous blood to bypass pulmonary metabolism and enter the arterial system directly, potentially triggering migraines. Although PFO closure has been shown to reduce the frequency and severity of migraine attacks, its long-term efficacy and underlying mechanisms require further investigation.
This study aims to explore the characteristics of glymphatic system function in PFO patients and its relationship with migraine symptoms, as well as the impact of PFO closure on glymphatic function and its role in alleviating migraine symptoms. A case-control and self-controlled before-after study design is adopted. Two groups of participants are enrolled: a case group consisting of PFO patients with significant right-to-left shunt and migraine, and a control group comprising PFO patients with significant shunt but without migraine. According to clinical guidelines and after obtaining informed consent, eligible patients in the case group undergo percutaneous PFO closure.
By comparing migraine symptoms and glymphatic function indicators both before and after the procedure between the two groups, the interventional effect of PFO closure and its potential mechanism will be investigated. The primary endpoint is the improvement in migraine symptoms, while the secondary endpoints include glymphatic function metrics. The findings of this study will provide new theoretical insights and clinical guidance for the management of PFO-related migraines.
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: 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.