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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Clínico Universitario
RECRUITING
Santiago De Compostela
Contact Information
Primary
Andrés Soto-Varela, Prof, PhD
andres.soto.varela@sergas.es
+34981951157
Backup
Ismael Arán-Tapia, PhD
ismaelaran.tapia@usc.es
+34663654574
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 54
Treatments
Active_comparator: Conventional Epley maneuver
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.
Experimental: Personalized Epley maneuver
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.
Sponsors
Collaborators: European Union, Instituto de Salud Carlos III
Leads: Hospital Clinico Universitario de Santiago

This content was sourced from clinicaltrials.gov