Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID06725966

Personalized Medicine to Treat Refractory Benign Paroxysmal Positional Vertigo Using Computational Fluid Dynamics From MRI Reconstructions

Led by Hospital Clinico Universitario de Santiago · Updated on 2024-12-10

54

Participants Needed

1

Research Sites

26 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

Benign paroxysmal positional vertigo (BPPV) is a common cause of vertigo, often treated successfully with standard canalith repositioning maneuvers (CRMs). However, about 12.5% of cases do not respond, leading to persistent symptoms. This trial investigates whether personalized CRMs, guided by computational fluid dynamics (CFD) based on MRI scans, can better treat patients with refractory posterior canal BPPV by tailoring maneuvers to individual inner ear anatomy. The study is a randomized, open-label, multicenter trial comparing personalized treatment to standard care. Participants are randomly assigned to one of two groups. The control group performs Brandt-Daroff exercises at home twice daily for 8 weeks and may receive repeated standard CRMs with a mechanized chair if symptoms persist. The intervention group also performs Brandt-Daroff exercises and undergoes MRI imaging to create personalized treatment models. If needed, personalized maneuvers using a mechanical rotation chair are applied. These maneuvers are repeated biweekly up to eight times until symptoms resolve. The study spans from January 2024 to December 2026. Participants undergo thorough vestibular assessments, including otoscopy, neurological exams, positional tests, and audiometry, with MRI scans if symptoms persist. Follow-up visits occur at 8 weeks, 10 weeks, and 6 months post-inclusion, with monitoring of symptom resolution via Dix-Hallpike tests and dizziness impact questionnaires. Researchers will measure symptom resolution rates, number of treatment sessions, and quality of life changes. Safety and adherence are monitored throughout, with data analyzed for treatment effectiveness and healthcare use.

CONDITIONS

Brief Title

Personalized Treatment of Refractory BPPV

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with posterior canal benign paroxysmal positional vertigo (BPPVp) based on Barany Society criteria
  • Recurrent vertigo episodes triggered by head position changes lasting less than 1 minute
  • Positional nystagmus observed during Dix-Hallpike test matching specified characteristics
  • Symptoms not explained by other causes
  • Symptoms persist after at least three repositioning maneuvers (Epley and/or Semont)
  • Age 18 to 100 years
  • Ability to understand and consent to study procedures
Not Eligible

You will not qualify if you...

  • Cognitive impairment preventing understanding of condition and study procedures
  • Medical conditions preventing performance of repositioning maneuvers
  • BPPV involving canals other than the posterior canal or bilateral posterior canal involvement
  • Low educational level impeding understanding of procedures and informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 pre-selection visit to confirm diagnosis and eligibility

Randomization and Baseline Assessment

Duration - 1 day

Participants provide informed consent and are randomized to either the control or study group. Baseline assessments including MRI are conducted to plan treatment.

1 visit (in-person) for randomization and baseline MRI

Treatment

Duration - 8 weeks plus up to 16 weeks of biweekly maneuvers

Participants perform Brandt-Daroff exercises at home twice daily for 8 weeks. If symptoms persist, repositioning maneuvers using a mechanized chair are repeated biweekly until symptom resolution or up to 8 repetitions.

Visits at 8 weeks, 10 weeks, and every 2 weeks thereafter as needed for up to 8 repetitions of maneuvers

Follow-up

Duration - Approximately 4 months after treatment completion

Participants are assessed 6 months after inclusion to evaluate symptom resolution, dizziness handicap, and number of treatment sessions.

1 visit (in-person) at 6 months after inclusion

Trial Site Locations

Total: 1 location

1

Hospital Clínico Universitario

Santiago de Compostela, A Coruña, Spain, 15706

Actively Recruiting

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Research Team

A

Andrés Soto-Varela, Prof, PhD

I

Ismael Arán-Tapia, PhD

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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Published Research Related To This Trial

Personalized medicine to treat refractory benign paroxysmal positional vertigo, through computational fluid dynamics analysis from magnetic resonance image reconstructions.

Marcos Rossi-Izquierdo, Sofia Santos-Pérez, Ismael Arán-Tapia...

https://pubmed.ncbi.nlm.nih.gov/40134694