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RECRUITING
NCT06725966
NA

Personalized Treatment of Refractory BPPV

Sponsor: Hospital Clinico Universitario de Santiago

View on ClinicalTrials.gov

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).

Official title: Personalized Medicine to Treat Refractory Benign Paroxysmal Positional Vertigo, Through Computational Fluid Dynamics Analysis From Magnetic Resonance Image Reconstructions

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2024-07-01

Completion Date

2026-12-31

Last Updated

2024-12-10

Healthy Volunteers

No

Interventions

PROCEDURE

Conventional Epley maneuver

Epley maneuver using a mechanized chair

PROCEDURE

Personalized Epley maneuver

Personalized Epley maneuver, using a mechanized chair

Locations (1)

Hospital Clínico Universitario

Santiago de Compostela, A Coruña, Spain