Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT06725966

Personalized Treatment of Refractory BPPV

Led by Hospital Clinico Universitario de Santiago · Updated on 2024-12-10

54

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

Sponsors

H

Hospital Clinico Universitario de Santiago

Lead Sponsor

I

Instituto de Salud Carlos III

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Personalized Treatment of Refractory BPPV

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with posterior canal benign paroxysmal positional vertigo (BPPVp) according to Barany Society criteria
  • Experience recurrent vertigo or instability triggered by lying down or head turning
  • Vertigo episodes last less than one minute
  • Positional nystagmus observed during Dix-Hallpike test with specific vertical and torsional components
  • Symptoms not explained by other causes
  • Symptoms persist after three repositioning maneuvers (Epley and/or Semont) without resolution
Not Eligible

You will not qualify if you...

  • Cognitive impairment preventing understanding of condition and procedures
  • Medical conditions that prevent performing repositioning maneuvers
  • BPPV involving canals other than the posterior canal or bilateral posterior canal involvement
  • Low educational level that might hinder understanding procedures and informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Clínico Universitario

Santiago de Compostela, A Coruña, Spain, 15706

Actively Recruiting

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Research Team

A

Andrés Soto-Varela, Prof, PhD

CONTACT

I

Ismael Arán-Tapia, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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