Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine

Xi'an Jiaotong University

Status: Enrolling

Conditions: Migraine Disorders; Right-to-Left Shunt, Cardiac; Patent Foramen Ovale

Treatments: Other: No Intervention; Device: Percutaneous Patent Foramen Ovale Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT07170176

XJTUIAF2025LSYY-609

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 to 60 years.
2. Diagnosed with patent foramen ovale (PFO) with significant right-to-left shunt.
3. For the case group: Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders (ICHD-3).
4. For the control group: No history of migraine.
5. Willing and able to provide written informed consent.
6. Education level of primary school or higher.

Exclusion criteria

1. Patients with a history of PFO closure or other migraine-related surgical treatments;
2. Patients with other severe cardiac or neurological diseases, mental disorders, or psychological conditions;
3. 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.);
4. Patients unable to complete migraine symptom assessments or imaging examinations due to other reasons.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

PFO with Migraine (Closure)

Experimental group

Description:

Patients with patent foramen ovale (PFO) and migraine receive percutaneous PFO closure intervention. This group will be assessed for migraine symptoms and glymphatic function before and after the procedure.

Treatment:

Device: Percutaneous Patent Foramen Ovale Closure

PFO without Migraine (Observation)

Other group

Description:

Patients with patent foramen ovale (PFO) but without migraine. This group does not receive closure intervention and serves as the control group for observational comparison. They will undergo the same assessment schedule as the intervention group.

Treatment:

Other: No Intervention