Personalized Treatment of Refractory BPPV

Recruiting now · Not applicable

Conditions studied: Benign Paroxysmal Positional Vertigo, Personalized Medicine

In brief

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).

Key facts

Study ID

NCT06725966

Run by

Hospital Clinico Universitario de Santiago

People needed

54

Starts

2024-07-01

Expected to finish

2026-12-31

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A. Diagnosed with BPPVp according to the Barany Society criteria:
• Recurrent episodes of vertigo or positional instability, triggered by lying down or turning the head in the supine position.
• Episodes lasting less than 1 minute.
• Positional nystagmus observed after a latency period during the Dix-Hallpike test (DHT), with an upward vertical component and a torsional component (clockwise on the left side and counterclockwise on the right).
• Symptoms not explained by any other cause.
• AND
• B. Refractory to otolith repositioning maneuvers (Epley and/or Semont maneuvers), with persistence of symptoms after three attempts.

You may not qualify if…

• Cognitive impairment that prevents understanding of their condition and the required procedures.
• Pathological conditions that hinder the execution of the maneuvers.
• BPPV involving canals other than the posterior canal or bilateral posterior canal involvement.
• Low educational level, which may impede understanding of the procedures and informed consent.

Where it is running

• Hospital Clínico Universitario — Santiago de Compostela, A Coruña, Spain (enrolling)

Full record on ClinicalTrials.gov

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