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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-14

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PFO with Migraine (Closure)

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.

Group Type EXPERIMENTAL

Percutaneous Patent Foramen Ovale Closure

Intervention Type DEVICE

Percutaneous transcatheter closure of patent foramen ovale (PFO) is a minimally invasive procedure. Under local anesthesia, a closure device is delivered via a catheter through the femoral vein to the heart to seal the PFO tunnel. The procedure is performed under fluoroscopic and echocardiographic guidance. This intervention aims to eliminate right-to-left shunt, which is hypothesized to improve migraine symptoms and glymphatic function.

PFO without Migraine (Observation)

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.

Group Type OTHER

No Intervention

Intervention Type OTHER

This arm does not receive the PFO closure procedure. Patients in this control group are observed under their standard care regimen without any study-specific intervention.

Interventions

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Percutaneous Patent Foramen Ovale Closure

Percutaneous transcatheter closure of patent foramen ovale (PFO) is a minimally invasive procedure. Under local anesthesia, a closure device is delivered via a catheter through the femoral vein to the heart to seal the PFO tunnel. The procedure is performed under fluoroscopic and echocardiographic guidance. This intervention aims to eliminate right-to-left shunt, which is hypothesized to improve migraine symptoms and glymphatic function.

Intervention Type DEVICE

No Intervention

This arm does not receive the PFO closure procedure. Patients in this control group are observed under their standard care regimen without any study-specific intervention.

Intervention Type OTHER

Other Intervention Names

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PFO Closure

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No