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Continuous vestibular implant stimulation partially restores eye-stabilizing reflexes
Peter J. Boutros, Desi P. Schoo, Mehdi Rahman, Nicolas S. Valentin, Margaret R. Chow, Andrianna I. Ayiotis, Brian J. Morris, Andreas Hofner, Aitor Morillo Rascon, Andreas Marx, Ross Deas, Gene Y. Fridman, Natan S. Davidovics, Bryan K. Ward, Carolina Treviño, Stephen P. Bowditch, Dale C. Roberts, Kelly E. Lane, Yoav Gimmon, Michael C. Schubert, John P. Carey, Andreas Jaeger, Charles C. Della Santina
Peter J. Boutros, Desi P. Schoo, Mehdi Rahman, Nicolas S. Valentin, Margaret R. Chow, Andrianna I. Ayiotis, Brian J. Morris, Andreas Hofner, Aitor Morillo Rascon, Andreas Marx, Ross Deas, Gene Y. Fridman, Natan S. Davidovics, Bryan K. Ward, Carolina Treviño, Stephen P. Bowditch, Dale C. Roberts, Kelly E. Lane, Yoav Gimmon, Michael C. Schubert, John P. Carey, Andreas Jaeger, Charles C. Della Santina
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Clinical Research and Public Health Neuroscience Otology

Continuous vestibular implant stimulation partially restores eye-stabilizing reflexes

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Abstract

BACKGROUND Bilateral loss of vestibular (inner ear inertial) sensation causes chronically blurred vision during head movement, postural instability, and increased fall risk. Individuals who fail to compensate despite rehabilitation therapy have no adequate treatment options. Analogous to hearing restoration via cochlear implants, prosthetic electrical stimulation of vestibular nerve branches to encode head motion has garnered interest as a potential treatment, but prior studies in humans have not included continuous long-term stimulation or 3D binocular vestibulo-ocular reflex (VOR) oculography, without which one cannot determine whether an implant selectively stimulates the implanted ear’s 3 semicircular canals.METHODS We report binocular 3D VOR responses of 4 human subjects with ototoxic bilateral vestibular loss unilaterally implanted with a Labyrinth Devices Multichannel Vestibular Implant System vestibular implant, which provides continuous, long-term, motion-modulated prosthetic stimulation via electrodes in 3 semicircular canals.RESULTS Initiation of prosthetic stimulation evoked nystagmus that decayed within 30 minutes. Stimulation targeting 1 canal produced 3D VOR responses approximately aligned with that canal’s anatomic axis. Targeting multiple canals yielded responses aligned with a vector sum of individual responses. Over 350–812 days of continuous 24 h/d use, modulated electrical stimulation produced stable VOR responses that grew with stimulus intensity and aligned approximately with any specified 3D head rotation axis.CONCLUSION These results demonstrate that a vestibular implant can selectively, continuously, and chronically provide artificial sensory input to all 3 implanted semicircular canals in individuals disabled by bilateral vestibular loss, driving reflexive VOR eye movements that approximately align in 3D with the head motion axis encoded by the implant.TRIAL REGISTRATION ClinicalTrials.gov: NCT02725463.FUNDING NIH/National Institute on Deafness and Other Communication Disorders: R01DC013536 and 2T32DC000023; Labyrinth Devices, LLC; and Med-El GmbH.

Authors

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

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Figure 2

Overview of the Labyrinth Devices MVI and study.

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Overview of the Labyrinth Devices MVI and study.
(A) The MVI stimulator ...
(A) The MVI stimulator comprises 3 fixation magnets, an inductive coil link, electrical current stimulator circuitry, stimulation electrode array, a stimulation reference electrode, and a recording reference electrode. The electrode array includes a 3-electrode shank for the (B, E3–E5) posterior canal, a forked subarray with 2 shanks for the (C, E6–E8) horizontal, and (D, E9–E11) anterior canals, and a stimulation reference electrode. (E) Surgical diagram illustrating electrode implantation sites, comprising surgical openings drilled in each of 3 canal ampullae and the common crus of 1 labyrinth. (F) The head-worn unit (HWU), magnetically coupled to subject MVI001’s scalp over his implanted stimulator, houses a 3D motion sensor and inductively supplies power and control signals to the implant. (G) The power and control unit (PCU, hanging on lanyard) houses a battery and control circuity. A Labyrinth Devices 3DBinoc video-oculography system (top) records horizontal, vertical, and torsional components of 3D eye position during VOR responses to natural and/or prosthetic stimulation. (H) Example 3D head velocity waveforms (corresponding to vectors in Figure 1D) modulate MVI pulse rate and amplitude. Input waveforms can be either actual head motion sensed by the HWU or synthetically generated by MVI fitting software. (I) Example pulse rate and amplitude modulation maps for each left ear canal. Top image portrays head velocity to pulse rate map; lower plot displays maps for pulse amplitude. Maps use non-zero pulse rate and current amplitude for 0°/s to evoke neural activity mimicking spontaneous afferent neuron discharge (dashed lines). The MVI encodes excitatory and inhibitory head motions via coordinated up- and downmodulation of pulse rate and amplitude (J and K). (L) This is an open-label, nonrandomized, early feasibility study of applicants self-identified as potential trial candidates. Reproduced by permission from Labyrinth Devices, LLC, ©2019.

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