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The Impact of Percutaneous Patent Foramen Ovale Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2026-01-16
150
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patent Foramen Ovale (PFO) is a common heart defect that may be linked to migraines, especially migraine with aura. Researchers are studying how PFO affects the brain's glymphatic system and its connection to migraine symptoms. They aim to understand if closing the PFO can improve migraines and glymphatic function, using a case-control design to compare patients with and without migraine who have PFO with significant right-to-left shunt. The study involves two groups: one with PFO and migraine who receive a minimally invasive percutaneous PFO closure procedure, and a control group with PFO but no migraine who do not receive closure. The closure uses a device inserted through a catheter to seal the PFO tunnel under imaging guidance. Both groups undergo assessments of migraine symptoms and glymphatic function before and six months after intervention or enrollment. Participants will be monitored for changes in migraine frequency and pain intensity, using tools like the Monthly Migraine Days and Visual Analogue Scale for pain. Glymphatic function is measured by imaging indexes such as the DTI-ALPS. The study takes place over at least six months post-procedure or enrollment, with the goal of understanding the effects and mechanisms of PFO closure on migraine and brain function.
CONDITIONS
Brief Title
Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 60 years
- Diagnosed with patent foramen ovale (PFO) with significant right-to-left shunt
- For case group: diagnosed with migraine (with or without aura) per International Classification of Headache Disorders (ICHD-3)
- For control group: no history of migraine
- Willing and able to provide written informed consent
- Education level of primary school or higher
You will not qualify if you...
- History of PFO closure or other migraine-related surgical treatments
- Severe cardiac or neurological diseases, mental disorders, or psychological conditions
- Contraindications to closure surgery or MRI scans, including severe infection, coagulation problems, pacemakers, aneurysm clips, metallic foreign bodies in the eye, or non-removable metal dentures
- Unable to complete migraine symptom assessments or imaging examinations for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day only
Participants with patent foramen ovale (PFO) and migraine receive a minimally invasive percutaneous PFO closure procedure under local anesthesia to seal the PFO tunnel. Participants without migraine are observed without undergoing the procedure.
1 visit (in-person)
Duration - 6 months
Participants are assessed for migraine symptoms and glymphatic function before and after the procedure or enrollment. This includes monitoring monthly migraine days and migraine pain intensity over 6 months.
Follow-up visits over 6 months
Trial Site Locations
Total: 2 locations
1
Luoyang Central Hospital
Luoyang, Henan, China, 471009
Actively Recruiting
2
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China, 300211
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Research Team
Y
Yang Yan
G
Guoliang Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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