Bilateral vestibulopathy patients’ perspectives on vestibular implant treatment: a qualitative study

Stiphout, Lisa van; Lucieer, Florence; Guinand, Nils; Fornos, Angelica Pérez; Berg, M.; Rompaey, Vincent Van; Widdershoven, Josine; Kingma, Herman; Joore, Manuela A.; Berg, Raymond van de

doi:10.1007/s00415-021-10920-z

Cited by 7 publications

(5 citation statements)

References 40 publications

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“…Changes in participant-reported disability and quality of life have already been reported after prolonged stimulation with a VI-only device [ 28 ]. Based on these findings and other previously reported perspectives in a BV patient population [ 44 ], it is expected that anticipated value by patients plays a crucial role in the early assessment of the usability of the device. Further assessment of the impact of the new VCI technology on the individual patient in their home-situation, their environment and even society as a whole will be planned during follow-up studies.…”

Section: Discussionsupporting

confidence: 67%

“…while walking on a treadmill), which may be disturbed by oscillopsia in patients with bilateral vestibulopathy [ 23 ]. Reduction of oscillopsia was frequently mentioned by BV patients when asked about their expectations of a vestibular implant [ 44 ], underlining the clinical importance of this symptom. While standing still and walking on a treadmill, patients will be shown Sloan optotypes (CDHKNORSVZ), which will be projected on a computer screen and presented one by one at different letter sizes (logarithm of the Minimum Angle of Resolution, logMAR).…”

Section: Methods/ Designmentioning

confidence: 99%

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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

Vermorken,

Volpe,

van Boxel

et al. 2024

PLoS ONE

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Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov: NCT04918745. Registered 28 April 2021.

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Section: Discussionsupporting

confidence: 67%

Section: Methods/ Designmentioning

confidence: 99%

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

Vermorken,

Volpe,

van Boxel

et al. 2024

PLoS ONE

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“…Changes in participant-reported disability and quality of life have already been reported after prolonged stimulation with a VI-only device (27). Based on these ndings and other previously reported perspectives in a BV patient population (39), it is expected that anticipated value by patients plays a crucial role in the early assessment of the usability of the device. Further assessment of the impact of the new VCI technology on the individual patient in their home-situation, their environment and even society as a whole will be planned during follow-up studies.…”

Section: Early Health Technology Assessment and Future Product Develo...mentioning

confidence: 62%

“…while walking on a treadmill), which may be disturbed by oscillopsia in patients with bilateral vestibulopathy (22). Reduction of oscillopsia was frequently mentioned by BV patients when asked about their expectations of a vestibular implant (39), underlining the clinical importance of this symptom. While standing still and walking on a treadmill, patients will be shown Sloan optotypes (CDHKNORSVZ), which will be projected on a computer screen and presented one by one at different letter sizes (logarithm of the Minimum Angle of Resolution, logMAR).…”

Section: Main Primary Outcomes: Functional E Cacy and Safety Endpointsmentioning

confidence: 99%

The VertiGO! Trial: study protocol for evaluating efficacy and safety of prolonged daily stimulation with a multichannel vestibulocochlear implant prototype

Vermorken

Volpe

Boxel

et al. 2022

Preprint

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Background: 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. Methods: 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 cross-over design will be implemented to evaluate the efficacy of three types of stimulation (i.e. two types of motion-modulated stimulation versus unmodulated baseline 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. A VCI will be implanted into all three semicircular canals via the intralabyrinthine approach, and into the cochlea. After CI-rehabilitation, the VI will be fitted and one day of baseline testing will be planned before three periods of prolonged VI stimulation take place. 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. Discussion: 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 electrical vestibulocochlear stimulation in the future. Trial registration: ClinicalTrials.gov: NCT04918745. Registered 28 April 2021

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“…Results from a qualitative study assessing symptoms of patients with BVP were used as foundation for the conceptual framework of the BVQ ( 6 , 46 ). This conceptual framework is centered around the full spectrum of BVP symptoms and categorizes them in three different domains: the physical, cognitive, and emotional domain.…”

Section: Conceptual Model and Contextmentioning

confidence: 99%

Development and Content Validity of the Bilateral Vestibulopathy Questionnaire

et al. 2022

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BackgroundTo date, the burden and severity of the full spectrum of bilateral vestibulopathy (BVP) symptoms has not yet been measured in a standardized manner. Since therapeutic interventions aiming to improve BVP symptoms are emerging, the need for a new standardized assessment tool that encompasses the specific aspects of BVP arises. Therefore, the aim of this study was to develop a multi-item Patient Reported Outcome Measure (PROM) that captures the clinically important symptoms of BVP and assesses its impact on daily life.MethodsThe development of the Bilateral Vestibulopathy Questionnaire (BVQ) consisted of two phases: (I) initial item generation and (II) face and content validity testing. Items were derived from a literature review and individual semi-structured interviews focusing on the full spectrum of reported BVP symptoms (I). Subsequently (IIa), individual patient interviews were conducted using “thinking aloud” and concurrent verbal probing techniques to assess the comprehensibility of the instructions, questions and response options, and the relevance, missing domains, or missing items. Interviews continued until saturation of input was reached. Finally, international experts with experience in the field of the physical, emotional, and cognitive symptoms of BVP participated in an online focus group to assess the relevance and comprehensiveness of the BVQ (IIb).ResultsThe BVQ consisted of two sections. The first section included 50 items scored on a six-point Likert scale arranged into seven constructs (i.e., imbalance, oscillopsia, other physical symptoms, cognitive symptoms, emotional symptoms, limitations and behavioral changes and social life). The second section consisted of four items, scored on a visual analog scale from 0 to 100, to inquire about limitations in daily life, perceived health and expectations regarding future recovery. Interviews with BVP patients [n = 8, 50% female, mean age 56 years (range 24–88 years)] and the expert meeting confirmed face and content validity of the developed BVQ.ConclusionThe BVQ, which was developed to assess the spectrum of BVP symptoms and its impact on daily life, proved to have good face and content validity. It can be used to characterize current self-reported symptoms and disability and to evaluate symptom burden before and after therapeutic interventions in future research and clinical practice.

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Bilateral vestibulopathy patients’ perspectives on vestibular implant treatment: a qualitative study

Cited by 7 publications

References 40 publications

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

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

The VertiGO! Trial: study protocol for evaluating efficacy and safety of prolonged daily stimulation with a multichannel vestibulocochlear implant prototype

Development and Content Validity of the Bilateral Vestibulopathy Questionnaire

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