Neurogenetics and cerebral blood flow in migraine with aura and patent foramen ovale
Official title: Association Between PFO and Migraine With Aura: A Case-Control Observational Study With Genetic and Neurosonological Analysis
Run by Azienda Usl di Bologna · NCT07349004 · Data updated 2026-11-12
This project will test whether adults with migraine with aura who have a patent foramen ovale (PFO) differ in specific genes, brain blood flow regulation, or platelet function from those without a PFO.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | November 24, 2025 |
| Study ends | November 2028 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07349004 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a diagnosis of migraine with aura according to ICHD-3 who can give informed consent and do not have congenital heart disease.
✕Probably not a fit
People without migraine with aura, those under 18, individuals with congenital heart disease, or those unable to undergo transcranial Doppler or blood draws are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PFOCUS is a prospective case-control observational project that will enroll 240 adults with migraine with aura and classify them as PFO-positive or PFO-negative based on contrast-enhanced transcranial Doppler. Participants attend a single visit for collection of clinical and demographic data, blood samples for genetic and platelet analyses, and a comprehensive neurosonological assessment including microembolic signal counts and cerebrovascular reactivity testing. Genetic analysis will focus on NOTCH3 variants and selected SNPs linked to small-vessel function while hemodynamic testing will assess cerebral blood flow regulation. The combined genetic, platelet, and hemodynamic data are intended to clarify biological mechanisms linking PFO and migraine with aura and their potential contribution to cerebrovascular risk.
Why it matters
Potential benefit: If successful, findings could help identify biological markers that explain stroke risk in migraine with aura and guide more personalized prevention or treatment strategies.
How similar studies have gone: Prior studies have repeatedly reported a higher prevalence of PFO in patients with migraine with aura and some preliminary links to NOTCH3 and other genetic markers exist, but definitive causal evidence is lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of migraine with aura (according to Chapter 1.2 of the International Classification of Headache Disorders, 3rd edition \[ICHD-3\]) * Age ≥ 18 years * Both sexes * Obtained written informed consent to participate in the study Exclusion Criteria: * History of congenital heart disease
Where it's running
-
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, Bo, Italy Recruiting
Study contacts
- Principal investigator: Matteo Paolucci — IRCCS Istituto delle Scienze Neurologiche di Bologna
- Study coordinator: Matteo Paolucci
- Email: matteo.paolucci@ausl.bologna.it
- Phone: +390513172087
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.