Personalized treatment for persistent vertigo caused by BPPV

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

This study is testing if personalized treatments for vertigo, based on each person's unique inner ear structure, can help people who haven't found relief from standard methods for BPPV.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Hospital Clinico Universitario de Santiago (other)
• Locations: 1 site (Santiago de Compostela, A Coruña)
• Trial ID: NCT06725966 on ClinicalTrials.gov

What this trial studies

This study focuses on patients suffering from refractory benign paroxysmal positional vertigo (BPPV), a common cause of vertigo that does not respond to standard treatments. It employs a personalized medicine approach using computational fluid dynamics (CFD) based on MRI scans to tailor canalith repositioning maneuvers (CRMs) to individual anatomical variations in the inner ear. Participants will be randomly assigned to receive either standard CRMs or personalized CRMs designed from their unique inner ear anatomy. The study aims to improve treatment outcomes for patients who have not found relief from conventional methods.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with unilateral refractory posterior canal BPPV.

Not a fit: Patients with cognitive impairments or those with BPPV involving canals other than the posterior canal may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce persistent vertigo symptoms in patients with refractory BPPV.

How similar studies have performed: While personalized approaches in treating BPPV are relatively novel, similar studies in other conditions have shown promising results.

Eligibility criteria

Inclusion Criteria:

* A. Diagnosed with BPPVp according to the Barany Society criteria:

  1. Recurrent episodes of vertigo or positional instability, triggered by lying down or turning the head in the supine position.
  2. Episodes lasting less than 1 minute.
  3. 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).
  4. 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.

Exclusion Criteria:

* 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 this trial is running

Santiago de Compostela, A Coruña

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

Study contacts

• Principal investigator: Andrés Soto-Varela, Prof, PhD — Complexo Hospitalario Universitario de Santiago
• Study coordinator: Andrés Soto-Varela, Prof, PhD

Conditions: Benign Paroxysmal Positional Vertigo, Personalized Medicine, BPPV, Benign paroxysmal positional vertigo, Computational fluid dynamics, MRI, Canalith repositioning maneuvers, Mechanical rotation chair