Personalized Medicine to Treat Refractory Benign Paroxysmal Positional Vertigo, Through Computational Fluid Dynamics Analysis From Magnetic Resonance Image Reconstructions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Rate of curation
研究概览
简要总结
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).
详细描述
- STUDY DESIGN This is an experimental, multicenter, open-label, randomized study (using balanced block randomization) with two parallel arms. The study targets patients with a definitive diagnosis of refractory posterior semicircular canal BPPV (BPPVp).
- STUDY PARTICIPANTS Study Period: From January 1, 2024, to December 31, 2026. Study Population: Patients diagnosed with BPPV. Target Population: Individuals >18 years of age, of both sexes, diagnosed with unilateral refractory BPPVp, from three Health Areas. Participants will be selected from patients attending the Otoneurology Unit of the Otolaryngology Departments of these three University Hospital Complexes.
To confirm the diagnosis and rule out other potential causes, all participants will undergo a complete otoneurological evaluation, including:
- Otoscopy.
- Basic neurological examination.
- Observation of spontaneous nystagmus (with and without gaze fixation).
- Clinical head impulse test (vHIT), including video-assisted evaluation.
- Positional tests (DHT, McClure test, and head hyperextension), with videonystagmographic recording.
- Pure-tone audiometry. In cases of refractory BPPV (lack of resolution after three therapeutic maneuvers), a magnetic resonance imaging (MRI) scan of the inner ears and posterior cranial fossa will be requested to rule out central neurological causes.
- RANDOMIZATION
Pre-selection Visit (Visit -1): Participants will undergo a comprehensive vestibular assessment to identify candidates with refractory BPPVp. The following tests will be included:
- Video-assisted head impulse test (vHIT) to assess for other vestibular pathologies.
- Dix-Hallpike test (DHT) to confirm the diagnosis of BPPVp.
- McClure test to exclude horizontal canal BPPV.
- Head hyperextension test to exclude superior canal BPPV.
- Dizziness Handicap Inventory (DHI) questionnaire adapted to Spanish, assessing perceived disability due to vertigo.
For posterior canal BPPV, it will be verified in the medical record that three repositioning maneuvers (Epley and/or Semont) were performed without symptom resolution.
Eligible participants will be given a detailed explanation of the study objectives and procedures, and will receive the approved Patient Information Sheet (PIS) to provide informed consent. 4. RANDOMIZATION PROCESS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •B. Refractory to otolith repositioning maneuvers (Epley and/or Semont maneuvers), with persistence of symptoms after three attempts.
排除标准
- •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.
结局指标
主要结局
Rate of curation
时间窗: 6 months
Percentage of participants in whom, after the maneuvers, no nystagmus is observed in the Dix and Hallpike test
次要结局
- Rate of resolution of symptomatology(6 months)
- DHI score(6 months)
- Number of sessions(6 months)
研究者
Andrés Soto-Varela
Professor and Chairman
Hospital Clinico Universitario de Santiago