# Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail

## TL;DR

The SPRING trial is testing if closing a heart defect called PFO is more effective than medication for reducing migraines.

## Contribution

The study introduces a new multicenter trial comparing PFO closure and medication for migraine treatment in real-world settings.

## Key findings

- The trial will assess if PFO closure leads to total migraine cessation.
- Echocardiography and transcranial Doppler will be used to monitor outcomes.
- Results will compare effectiveness and safety in real-world clinical practice.

## Abstract

Migraine is a leading cause of disability worldwide. Several retrospective studies have suggested that the closure of the Patent Foramen Ovale (PFO) may provide relief from migraines. However, three randomized controlled trials did not meet their primary endpoints regarding migraine cessation, reduction in monthly migraine days, and responder rates.

The SPRING study is a multicenter, prospective, randomized, and open-label trial designed to compare the effectiveness and safety of PFO closure versus medication in the relief of migraines. The primary endpoint is the total cessation of migraines, as recorded in patient headache diaries during the follow-up period. Additional diagnostic tools include echocardiography with agitated saline contrast, transcranial Doppler, and routine laboratory measurements.

The SPRING trial aims to assess the effectiveness and safety of PFO closure versus medication in mitigating migraines in real-world settings. (Clinical Trails ID: NCT04946734).