Personalized Treatment of Refractory BPPV

NCT06725966 | Recruiting

• 1 other identifier: PI23/0024
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Benign Paroxysmal Positional Vertigo; Personalized Medicine

Keywords

BPPV; Benign paroxysmal positional vertigo; Computational fluid dynamics; MRI; Canalith repositioning maneuvers; Mechanical rotation chair

Outcome Measures

Primary Outcomes (1)

• Rate of curation

  Percentage of participants in whom, after the maneuvers, no nystagmus is observed in the Dix and Hallpike test

  6 months

Secondary Outcomes (3)

• Rate of resolution of symptomatology

  6 months

• DHI score

  6 months

• Number of sessions

  6 months

Study Arms (2)

Conventional Epley maneuver

ACTIVE COMPARATOR

Participants will be advised to perform Brandt-Daroff exercises at home twice daily for 8 weeks. An MRI of the inner ear and posterior cranial fossa will also be requested. If the exercises are ineffective, repositioning maneuvers using a mechanized chair will be repeated biweekly until symptom resolution.

Procedure: Conventional Epley maneuver

Personalized Epley maneuver

EXPERIMENTAL

Participants will perform Brandt-Daroff exercises at home twice daily for 8 weeks. An MRI will be conducted, and based on the images, a personalized mathematical model will be created to modify the angles of the repositioning maneuver. If the exercises are ineffective, the personalized maneuver will be performed using a mechanized chair.

Procedure: Personalized Epley maneuver

Interventions

Conventional Epley maneuver PROCEDURE

Epley maneuver using a mechanized chair

Conventional Epley maneuver

Personalized Epley maneuver PROCEDURE

Personalized Epley maneuver, using a mechanized chair

Personalized Epley maneuver

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead
• Instituto de Salud Carlos III: collaborator
• European Union: collaborator

Study Sites (1)

Hospital Clínico Universitario

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Related Publications (1)

• Rossi-Izquierdo M, Santos-Perez S, Aran-Tapia I, Blanco-Ulla M, Aran-Gonzalez I, Vaamonde-Sanchez-Andrade I, Franco-Gutierrez V, Perez-Munuzuri V, Munuzuri AP, Soto-Varela A. Personalized medicine to treat refractory benign paroxysmal positional vertigo, through computational fluid dynamics analysis from magnetic resonance image reconstructions. Front Neurol. 2025 Mar 11;16:1561356. doi: 10.3389/fneur.2025.1561356. eCollection 2025.

  PMID: 40134694 DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrés Soto-Varela, Prof, PhD

  Complexo Hospitalario Universitario de Santiago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrés Soto-Varela, Prof, PhD

CONTACT

+34981951157; andres.soto.varela@sergas.es

Ismael Arán-Tapia, PhD

CONTACT

+34663654574; ismaelaran.tapia@usc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Model Details: Experimental, multicenter, open-label, randomized study (using balanced block randomization) with two parallel arms

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

ES (1)