The VertiGO! Trial protocol: A prospective, single-center, patient-blinded study to evaluate efficacy and safety of prolonged daily stimulation with a multichannel vestibulocochlear implant prototype in bilateral vestibulopathy patients

• DOI: 10.1371/journal.pone.0301032
• Publication Date: 2024-03-28T17:44:53Z
• Authors: Bernd L. Vermorken; Benjamin Volpe; Stan C. J. van Boxel; Joost J. A. Stult...; Marc van Hoof; Rik Marcellis; Elke Loos; Alexander van Soest; Chris McCrum; Kenneth Meijer; Nils Guinand; Angélica Pérez Fo...; Vincent van Rompaey; Elke Devocht; Raymond van de Berg
• Keywords: Cochlear Implants/adverse effects; Cross-Over Studies; Cochlear Implants / adverse effects; Bilateral Vestibulopathy; Science; Q; R; info:eu-repo/classification/ddc/616.8; Study Protocol; Cochlear Implants; Humans; Medicine; Single-Blind Method; Human medicine; Prospective Studies; Vertigo/therapy; Randomized Controlled Trials as Topic

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