Study of Percutaneous Closure of Patent Foramen Ovale and Its Effects on Glymphatic Function and Migraine Symptoms in Adults

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 brains 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.

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