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BackgroundA combined vestibular (VI) and cochlear implant (CI) device, also known as the vestibulocochlear implant (VCI), was previously developed to restore both vestibular and auditory function. A new refined prototype is currently being investigated. This prototype allows for concurrent multichannel vestibular and cochlear stimulation. Although recent studies showed that VCI stimulation enables compensatory eye, body and neck movements, the constraints in these acute study designs prevent them from creating more general statements over time. Moreover, the clinical relevance of potential VI and CI interactions is not yet studied. The VertiGO! Trial aims to investigate the safety and efficacy of prolonged daily motion modulated stimulation with a multichannel VCI prototype.MethodsA single-center clinical trial will be carried out to evaluate prolonged VCI stimulation, assess general safety and explore interactions between the CI and VI. A single-blind randomized controlled crossover design will be implemented to evaluate the efficacy of three types of stimulation. Furthermore, this study will provide a proof-of-concept for a VI rehabilitation program. A total of minimum eight, with a maximum of 13, participants suffering from bilateral vestibulopathy and severe sensorineural hearing loss in the ear to implant will be included and followed over a five-year period. Efficacy will be evaluated by collecting functional (i.e. image stabilization) and more fundamental (i.e. vestibulo-ocular reflexes, self-motion perception) outcomes. Hearing performance with a VCI and patient-reported outcomes will be included as well.DiscussionThe proposed schedule of fitting, stimulation and outcome testing allows for a comprehensive evaluation of the feasibility and long-term safety of a multichannel VCI prototype. This design will give insights into vestibular and hearing performance during VCI stimulation. Results will also provide insights into the expected daily benefit of prolonged VCI stimulation, paving the way for cost-effectiveness analyses and a more comprehensive clinical implementation of vestibulocochlear stimulation in the future.Trial registrationClinicalTrials.gov: NCT04918745. Registered 28 April 2021.

OBJECTIVES:To identify predictive factors for falls in patients with bilateral vestibulopathy (BV). Specific variables contributing to the general work-up of a vestibular patient were compared between BV patients experiencing falls and those who did not. DESIGN:Prospective multi-centric cohort study. SETTING:Department of Otorhinolaryngology & Head and Neck Surgery at two tertiary referral centers: Antwerp University Hospital and Maastricht University Medical Center. PARTICIPANTS:In total, 119 BV patients were included. BV diagnosis was defined in accordance with the diagnostic BV criteria, established by the Bárány Society in 2017. MAIN OUTCOME MEASURES:Patients were divided into fallers and non-fallers, depending on the experience of one or more falls in the preceding 12 months. Residual vestibular function on caloric testing, rotatory chair testing, video head impulse test (vHIT) and cervical vestibular evoked myogenic potentials (cVEMP) was evaluated as a predictive factor for falls. Furthermore, hearing function (speech perception in noise (SPIN)), sound localization performance, etiology, disease duration, sport practice, scores on the Dizziness Handicap Inventory (DHI) and the Oscillopsia Severity Questionnaire (OSQ) were compared between fallers and non-fallers. RESULTS:Forty-five (39%) patients reported falls. In a sub-analysis in the patients recruited at UZA (n = 69), 20% experienced three or more falls and three patients (4%) suffered from severe fall-related injuries. The DHI score and the OSQ score were significantly higher in fallers. Residual vestibular function, SPIN, sound localization performance, etiology, disease duration, age and sport practice did not differ between fallers and non-fallers. CONCLUSIONS:Falls and (severe) fall-related injuries are frequent among BV patients. A DHI score > 47 and an OSQ score > 27.5 might be indicative for BV patients at risk for falls, with a sensitivity of 70% and specificity of 60%. Residual vestibular function captured by single vestibular tests (vHIT, calorics, rotatory chair, cVEMP) or by overall vestibular function defined as the number of impaired vestibular sensors are not suitable to distinguish fallers and non-fallers in a BV population.