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
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26 weeks
Total Duration
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Brief Title
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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
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
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
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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.
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...