Closing a PFO to improve glymphatic function and migraine symptoms
The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
This study will see if closing a patent foramen ovale (PFO) improves glymphatic system function and reduces migraine attacks in adults with PFO and migraine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 2 sites (Luoyang, Henan and 1 other locations) |
| Trial ID | NCT07170176 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adults with significant right-to-left shunt due to PFO and compares them with control participants without migraine using a case-control and self-controlled before-and-after design. Participants in the case group undergo percutaneous PFO closure and are followed with imaging of glymphatic system metrics plus standardized migraine symptom assessments before and after the procedure. Controls undergo the same imaging and clinical assessments without closure to characterize baseline differences. The design aims to link changes in glymphatic measures to changes in migraine frequency and severity over time.
Who should consider this trial
Good fit: Adults aged 18–60 with a diagnosed PFO and significant right-to-left shunt who meet migraine diagnostic criteria (case group) or have no history of migraine (control group) and can undergo MRI and give informed consent are ideal candidates.
Not a fit: Patients without a significant right-to-left shunt, those whose migraines have other clear causes, or those with contraindications to closure or MRI are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, PFO closure could improve glymphatic clearance and lead to fewer or less severe migraine attacks for selected patients.
How similar studies have performed: Prior clinical work has reported migraine improvement after PFO closure in some patients, especially with aura, but results have been mixed and the underlying mechanisms remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Luoyang, Henan and 1 other locations
- Luoyang Central Hospital — Luoyang, Henan, China (Recruiting)
- The Second Hospital of Tianjin Medical University — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yang Yan
- Email: yangyan3@xjtu.edu.cn
- Phone: 0086-029-85323865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.