Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Hospital Clínico Universitario
Santiago de Compostela, A Coruña, Spain, 15706
Actively Recruiting
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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