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

NCT07170176 | Recruiting

• 1 other identifier: XJTUIAF2025LSYY-609
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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 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.

Conditions

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

Keywords

Patent Foramen Ovale; Migraine; Glymphatic System; PFO Closure

Outcome Measures

Primary Outcomes (1)

• Monthly Migraine Days (MMD)

  The number of days with migraine headache per month, as recorded by participants in a daily headache diary. The change in MMD from baseline to 6-month follow-up will be calculated. A decrease in MMD indicates improvement.

  For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.

Secondary Outcomes (2)

• Migraine Pain Intensity (VAS Score)

  The pain intensity of migraine attacks as measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). The change in VAS score from baseline to the 6-month timepoint will be calculated. A negative change indicates

• DTI-ALPS Index

  For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.

Study Arms (2)

PFO with Migraine (Closure)

EXPERIMENTAL

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.

Device: Percutaneous Patent Foramen Ovale Closure

PFO without Migraine (Observation)

OTHER

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.

Other: No Intervention

Interventions

Percutaneous Patent Foramen Ovale Closure 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.

Also known as: PFO Closure

PFO with Migraine (Closure)

No Intervention 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.

PFO without Migraine (Observation)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (2)

Luoyang Central Hospital

Luoyang, Henan, 471009, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300211, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yang Yan

CONTACT

0086-029-85323865; yangyan3@xjtu.edu.cn

Guoliang Li

CONTACT

liguoliang_med@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 12, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (2)