Neurogenetics and cerebral blood flow in migraine with aura and patent foramen ovale
Association Between PFO and Migraine With Aura: A Case-Control Observational Study With Genetic and Neurosonological Analysis
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 |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT07349004 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, BO
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.