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.
<h4>Background</h4>A 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...
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Public Library of Science (PLoS)
2024-01-01
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| author | Bernd L Vermorken Benjamin Volpe Stan C J van Boxel Joost J A Stultiens Marc van Hoof Rik Marcellis Elke Loos Alexander van Soest Chris McCrum Kenneth Meijer Nils Guinand Angélica Pérez Fornos Vincent van Rompaey Elke Devocht Raymond van de Berg |
| author_facet | Bernd L Vermorken Benjamin Volpe Stan C J van Boxel Joost J A Stultiens Marc van Hoof Rik Marcellis Elke Loos Alexander van Soest Chris McCrum Kenneth Meijer Nils Guinand Angélica Pérez Fornos Vincent van Rompaey Elke Devocht Raymond van de Berg |
| author_sort | Bernd L Vermorken |
| collection | DOAJ |
| description | <h4>Background</h4>A 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.<h4>Methods</h4>A 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.<h4>Discussion</h4>The 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.<h4>Trial registration</h4>ClinicalTrials.gov: NCT04918745. Registered 28 April 2021. |
| format | Article |
| id | doaj-art-f68b6e738247440283a3e1ae335bc50f |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Public Library of Science (PLoS) |
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| spelling | doaj-art-f68b6e738247440283a3e1ae335bc50f2025-01-04T05:31:03ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01193e030103210.1371/journal.pone.0301032The 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.Bernd L VermorkenBenjamin VolpeStan C J van BoxelJoost J A StultiensMarc van HoofRik MarcellisElke LoosAlexander van SoestChris McCrumKenneth MeijerNils GuinandAngélica Pérez FornosVincent van RompaeyElke DevochtRaymond van de Berg<h4>Background</h4>A 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.<h4>Methods</h4>A 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.<h4>Discussion</h4>The 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.<h4>Trial registration</h4>ClinicalTrials.gov: NCT04918745. Registered 28 April 2021.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0301032&type=printable |
| spellingShingle | Bernd L Vermorken Benjamin Volpe Stan C J van Boxel Joost J A Stultiens Marc van Hoof Rik Marcellis Elke Loos Alexander van Soest Chris McCrum Kenneth Meijer Nils Guinand Angélica Pérez Fornos Vincent van Rompaey Elke Devocht Raymond van de Berg 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. PLoS ONE |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0301032&type=printable |
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