The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Luoyang Central Hospital
RECRUITING
Luoyang
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
Contact Information
Primary
Yang Yan
yangyan3@xjtu.edu.cn
0086-029-85323865
Backup
Guoliang Li
liguoliang_med@163.com
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
Experimental: 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.
Other: 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.
Sponsors
Leads: First Affiliated Hospital Xi'an Jiaotong University

This content was sourced from clinicaltrials.gov