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RECRUITING
NCT07824297

NAIF 2.0 - COGNIFY

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

View on ClinicalTrials.gov

Summary

The goal of this observational study is to learn whether intracranial dural arteriovenous fistulae, abnormal connections between arteries and veins in the covering of the brain, may affect a brain's waste-clearance system, known as the glymphatic system. The main question it aims to answer is: "Does glymphatic system function change after routine endovascular embolization of an intracranial dural arteriovenous fistula?" Participants who are already scheduled to receive endovascular embolization as part of their regular medical care will undergo advanced brain MRI before treatment and again about 6 months after treatment. Researchers will compare the MRI findings before and after embolization to explore whether treatment is associated with changes in glymphatic-related brain imaging markers.

Official title: NAIF 2.0 - COGNIFY: Cognitive Impairment in Patients With Intracranial Dural Arteriovenous Fistulae: Exploration & Understanding

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2026-01-01

Completion Date

2029-08-01

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Brain MRI

Participants will undergo a brain MRI on a 3T scanner at baseline assessment and approximately 6 months after endovascular embolization. The MRI protocol includes routinary morphologic sequences (e.g., 3D T1-weighted imaging, T2-weighted FLAIR, susceptibility-weighted imaging), as well as a multi-shell diffusion MRI with multiple b-values and gradient directions. These sequences will be used to assess conventional brain findings and diffusion-derived metrics potentially related to glymphatic function, including DTI-ALPS, DKI-MK and FW imaging. The main otcome of the study is to evaluate changes in these metrics in relation to treatment.

Locations (3)

Università di Bologna

Bologna, Italy

Hospital Universitario Vall D'Hebron

Barcelona, Spain

University of Oxford

Oxford, United Kingdom