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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07170176
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-07
• Study First Submitted QC: 2025-09-07
• Last Update Submitted: 2025-09-07
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-12-30
• Primary Completion: 2027-10-25
• Study Completion: 2028-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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. Prior history of PFO closure or other migraine surgery.
2. Comorbid with other severe cardiac (e.g., complex congenital heart disease) or neurological diseases.
3. Use of medications that may affect migraine symptoms (e.g., prophylactic migraine medications, antidepressants) within the past 3 months.
4. Contraindications to the PFO closure procedure (e.g., active infection, coagulation dysfunction).
5. Inability to complete migraine symptom assessments or MRI examinations (e.g., claustrophobia, presence of MRI-incompatible implants).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Monthly Migraine Days (MMD)	For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.	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.

Secondary Outcome Measures

Name	Time	Method
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	The change in pain intensity of migraine attacks as measured by the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). A negative change indicates improvement.
DTI-ALPS Index	For the intervention arm, this is 6 months post-procedure. For the control arm, this is 6 months post-enrollment.	The Diffusion Tensor Imaging-Alignment along the Perivascular Space (DTI-ALPS) index is a non-invasive MRI biomarker used to assess glymphatic system function. It is calculated by obtaining diffusion tensor imaging (DTI) sequences on a 3.0T MRI scanner and measuring the diffusion coefficients along the x, y, and z axes in specific regions of interest (ROIs) near the lateral ventricles. The change in the DTI-ALPS index from baseline to the 6-month timepoint will be calculated. A positive change suggests improved glymphatic activity.