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

RecruitingNAAges 18 Years - 60 YearsAllFirst Affiliated Hospital Xi'an Jiaotong Universi…
NCT07170176 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Percutaneous Patent Foramen Ovale Closure
  • No Intervention
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Where

2 sites
Luoyang Central Hospital
Luoyang, China
The Second Hospital of Tianjin Medical University
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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