NCT07170176Recruiting
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 7 Sept 2025
- Start date
- 14 Jan 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Migraine
- NCT number
- NCT07170176
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 14 Jan 2026 to the primary completion date, 31 May 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.);
Other
- Patients unable to complete migraine symptom assessments or imaging examinations due to other reasons.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Luoyang Central Hospital Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.