Continuous vestibular implant stimulation partially restores eye-stabilizing reflexes

Boutros, Peter J.; Schoo, Desi P.; Rahman, Mehdi A.; Valentin, Nicolas S.; Chow, Margaret R.; Ayiotis, Andrianna I; Morris, Brian J.; Hofner, Andreas; Rascon, Aitor Morillo; Marx, Andreas; Deas, Ross W.; Fridman, Gene Y.; Davidovics, Natan S.; Ward, Bryan K.; Treviño, Carolina; Bowditch, Stephen; Roberts, Dale; Lane, Kelly E; Gimmon, Yoav; Schubert, Michael C.; Carey, John P.; Jaeger, Andreas; Santina, Charles C. Della

doi:10.1172/jci.insight.128397

Cited by 52 publications

(74 citation statements)

References 70 publications

(111 reference statements)

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“…When using the air caloric test, it is advised to irrigate at 8 liters/min for at least 60 seconds to be able to comply with criterion C, since air might be a less strong stimulus than water. This paradigm is advised based on the experience with the air caloric test in patients following VI-implantation [29]. In case of a 60 sec stimulus (water or air), <10 • /sec is used as a criterion rather than ≤6 • /sec because stimulation for an additional 30 sec beyond the initial 30 sec of stimulation is very likely to increase the magnitude of the response.…”

Section: The Caloric Testmentioning

confidence: 99%

“…A VI-implantation attempts to serve as an artificial replacement of the peripheral vestibular organ and it does not replace the whole vestibular nerve or central vestibular system. Only few human implantations have been performed until now [21,23,29,36] and the influence of deficits of the vestibular nerve and central vestibular system on performance of the VI have not been studied yet. However, it is expected that with current techniques, the VI will not effectively treat a deficit of the vestibular nerve or the central vestibular system.…”

Section: Implanting Only Bvp Of Peripheral Originmentioning

confidence: 99%

“…Data are not yet available on the effectiveness of VI-implantation and the influence of etiology and duration of the disease on efficacy. It is hypothesized that "dying back" of the vestibular nerve could compromise effective vestibular stimulation, although long standing vestibular losses have also shown promising results with a VI [29,30,35,36]. For now, it is preferred to avoid a "wait and see" period of more than six months, if possible.…”

Section: Timing Of Implantation and Rehabilitationmentioning

confidence: 99%

“…Research in humans has demonstrated feasibility of the VI to partially restore vestibular function. First, it was reproducibly shown that it is possible to increase the vestibulo-ocular reflex (VOR) gain with a VI [27][28][29][30], and to influence the vestibulocollic and vestibulospinal reflexes [31,32]. Secondly, functional benefits were demonstrated by restoring the dynamic visual acuity in close-to-reality situations and in the high-frequency range [33,34].…”

Section: Introductionmentioning

confidence: 99%

“…Currently, one of the main current questions in the field of VI research is: Whom should be implanted for research? Until now, no uniform implantation criteria for research have been established and as a consequence, research groups have applied different criteria [21,29,36]. Therefore, in order to facilitate better comparison between future clinical trials regarding efficacy, safety, and other outcome measures, there is a need for establishing uniform criteria for the selection of patients appropriate for implantation of a VI.…”

Section: Introductionmentioning

confidence: 99%

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The vestibular implant: Opinion statement on implantation criteria for research1

Berg

Ramos²,

Rompaey

et al. 2020

VES

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This opinion statement proposes a set of candidacy criteria for vestibular implantation of adult patients with bilateral vestibulopathy (BVP) in a research setting. The criteria include disabling chronic symptoms like postural imbalance, unsteadiness of gait and/or head movement-induced oscillopsia, combined with objective signs of reduced or absent vestibular function in both ears. These signs include abnormal test results recorded during head impulses (video head impulse test or scleral coil technique), bithermal caloric testing and rotatory chair testing (sinusoidal stimulation of 0.1 Hz). Vestibular implant (VI) implantation criteria are not the same as diagnostic criteria for bilateral vestibulopathy. The major difference between VI-implantation criteria and the approved diagnostic criteria for BVP are that all included vestibular tests of semicircular canal function (head impulse test, caloric test, and rotatory chair test) need to show significant impairments of vestibular function in the implantation criteria. For this, a two-step paradigm was developed. First, at least one of the vestibular tests needs to fulfill stringent criteria, close to those for BVP. If this is applicable, then the other vestibular tests have to fulfill a second set of criteria which are less stringent than the original criteria for BVP. If the VI-implantation is intended to excite the utricle and/or saccule (otolith stimulation), responses to cervical and ocular vestibular evoked myogenic potentials must be absent in addition to the above mentioned abnormalities of semicircular canal function. Finally, requirements for safe and potentially effective stimulation should be met, including implanting patients with BVP of peripheral origin only, and assessing possible medical and psychiatric contraindications.

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Section: The Caloric Testmentioning

confidence: 99%

Section: Implanting Only Bvp Of Peripheral Originmentioning

confidence: 99%

Section: Timing Of Implantation and Rehabilitationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The vestibular implant: Opinion statement on implantation criteria for research1

Berg

Ramos²,

Rompaey

et al. 2020

VES

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Patient-Reported Outcomes After Vestibular Implantation for Bilateral Vestibular Hypofunction

Ayiotis,

Schoo,

Fernandez Brillet

et al. 2024

JAMA Otolaryngol Head Neck Surg

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ImportanceStandard-of-care treatment proves inadequate for many patients with bilateral vestibular hypofunction (BVH). Vestibular implantation is an emerging alternative.ObjectiveTo examine patient-reported outcomes from prosthetic vestibular stimulation.Design, Setting, and ParticipantsThe Multichannel Vestibular Implant (MVI) Early Feasibility Study is an ongoing prospective, nonrandomized, single-group, single-center cohort study conducted at Johns Hopkins Hospital that has been active since 2016 in which participants serve as their own controls. The study includes adults with severe or profound adult-onset BVH for at least 1 year and inadequate compensation despite standard-of-care treatment. As of March 2023, 12 candidates completed the eligibility screening process.InterventionThe MVI system electrically stimulates semicircular canal branches of the vestibular nerve to convey head rotation.Main Outcomes and MeasuresPatient-reported outcome instruments assessing dizziness (Dizziness Handicap Inventory [DHI]) and vestibular-related disability (Vestibular Disorders–Activities of Daily Living [VADL]). Health-related quality of life (HRQOL) assessed using the Short Form-36 Utility (SF36U) and Health Utilities Index Mark 3 (HUI3), from which quality-adjusted life-years were computed.ResultsTen individuals (5 female [50%]; mean [SD] age, 58.5 [5.0] years; range, 51-66 years) underwent unilateral implantation. A control group of 10 trial applicants (5 female [50%]; mean [SD] age, 55.1 [8.5] years; range, 42-73 years) completed 6-month follow-up surveys after the initial application. After 0.5 years of continuous MVI use, a pooled mean (95% CI) of within-participant changes showed improvements in dizziness (DHI, −36; 95% CI, −55 to −18), vestibular disability (VADL, −1.7; 95% CI, −2.6 to −0.7), and HRQOL by SF36U (0.12; 95% CI, 0.07-0.17) but not HUI3 (0.02; 95% CI, −0.22 to 0.27). Improvements exceeded minimally important differences in the direction of benefit (exceeding 18, 0.65, and 0.03, respectively, for DHI, VADL, and SF36U). The control group reported no mean change in dizziness (DHI, −4; 95% CI, −10 to 2), vestibular disability (VADL, 0.1; 95% CI, −0.9 to 1.1) or HRQOL per SF36U (0; 95% CI, −0.06 to 0.05) but an increase in HRQOL per HUI3 (0.10; 95% CI, 0.04-0.16). Lifetime HRQOL gain for MVI users was estimated to be 1.7 quality-adjusted life-years (95% CI, 0.6-2.8) using SF36U and 1.4 (95% CI, −1.2 to 4.0) using HUI3.Conclusions and RelevanceThis cohort study found that vestibular implant recipients report vestibular symptom improvements not reported by a control group. These patient-reported benefits support the use of vestibular implantation as a treatment for bilateral vestibular hypofunction.

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Vestibular Implant Surgery

Schoo,

Ward,

Chow

et al. 2023

The Laryngoscope

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The Multichannel Vestibular Implant Early Feasibility Study is supported by NIH (NIDCD R01DC013536 and U01DC019364; NIA R01AG076701) and by Labyrinth Devices, LLC in collaboration with MED-EL GmbH. DPS and BKW received support from NIDCD T32DC000027. MRC, AIA, PJB, and BJM received support from NIDCD T32DC000023. CFB currently receives support from "la Caixa" Foundation (ID 100010434), fellowship code LCF/BQ/EU21/11890107. CCDS founded and holds an equity interest in Labyrinth Devices, LLC. The terms of this arrangement are managed in accordance with Johns Hopkins University policy. MED-EL GmbH has provided funding to Johns Hopkins University for preclinical research related to vestibular implantation.CCDS founded and holds an equity interest in Labyrinth Devices, LLC.

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Continuous vestibular implant stimulation partially restores eye-stabilizing reflexes

Cited by 52 publications

References 70 publications

The vestibular implant: Opinion statement on implantation criteria for research1

The vestibular implant: Opinion statement on implantation criteria for research1

Patient-Reported Outcomes After Vestibular Implantation for Bilateral Vestibular Hypofunction

Vestibular Implant Surgery

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