Clinical Trial

Personalized Treatment of Refractory BPPV

Recruiting
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Record status
This record was last updated December 10, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Background: Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, often effectively treated with standard canalith repositioning maneuvers (CRMs). However, approximately 12.5% of cases remain refractory, leading to persistent symptoms and increased healthcare burden. Variations in the anatomical orientation of the semicircular canals (SCCs) may explain the resistance to conventional maneuvers. This study explores a personalized medicine approach, utilizing computational fluid dynamics (CFD) based on MRI reconstructions to tailor CRMs with the help of mechanical rotation chair according to individual inner ear anatomy. Methods: The investigators conducted a randomized, multicenter, open-label study targeting patients with refractory posterior canal BPPV. Participants were allocated to either a control group (receiving repeated standard CRMs and Brandt-Daroff exercises) or an intervention group (receiving personalized CRMs based on CFD simulations derived from MRI scans). The intervention group's maneuvers were executed using a mechanical rotational chair designed for precise angulation. Primary outcomes included resolution of nystagmus and vertigo symptoms, while secondary outcomes measured the reduction in healthcare visits and improved quality of life (Dizziness Handicap Inventory score).
Trial Details
NCT Number NCT06725966
Lead Sponsor Hospital Clinico Universitario de Santiago
Collaborators: Instituto de Salud Carlos III, European Union
Conditions Benign Paroxysmal Positional Vertigo, Personalized Medicine
Enrollment 54 participants
Start Date 2024-07-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-10