Clinical trial NCT05246553: Electrical Stimulation of the Peripheral Vestibular System in Order to Develop a Vestibular Implant
Official title: Electrical Stimulation of the Peripheral Vestibular System in Order to Develop a Vestibular Implant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Disorder
Bilateral Vestibulopathy
Bilateral Vestibular Loss
Keywords: Vestibular
Prosthesis
Otorhinolaryngologic Diseases
Electrical Stimulation
Vestibular Implant
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
name: Maastricht University Medical Center
name: Massachusetts Eye and Ear Infirmary
First posted: 2022-02-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study has three main goals (1) to explore the effects of electrical stimulations of the peripheral vestibular system(2) to assess the potential of this technique to rehabilitate basic vestibular functions in patients with severe bilateral vestibulopathy, and (3) to take advantage of the unprecedented experimental paradigm provided by the vestibular implant to increase our fundamental knowledge on the contribution of peripheral vestibular function to posture, gait and higher order sensory functions, mechanisms that remain poorly understood.

Detailed description: The investigators will carry out a thorough investigation of the effects of electrical stimulation on vestibular and auditory function in a group of patients implanted with a modified cochlear implant providing extracochlear electrodes implanted in the vicinity of the of the ampullary nerve branches. These results will be compared to similar measurements carried out in a group of age and sex-matched healthy controls, in a group of patients with bilateral and unilateral vestibulopathy, and also in a group of patients implanted with a cochlear implant and normal vestibular function. The protocol comprises the following specific measurements:

1. Clinical evaluation of auditory function: pure-tone and speech audiometry.
2. Clinical evaluation of vestibular function: clinical evaluation of the vestibulo-ocular reflex (e.g., video-nystagmography, video-head impulse tests), and of the otolithic function (vestibular evoked myogenic potentials).
3. Dynamic visual acuity: loss of visual acuity while walking in a treadmill at controlled speed, compared to the static (standing in place) of the subject.
4. Auditory and vestibular brainstem evoked potentials.
5. Electroencephalography.
6. Temporal Binding Window: maximal time interval separating two different types of sensory stimuli (visual, auditory and vestibular) within which the subject still perceives them as simultaneous.
7. Psychophysical motion detection tests: motion perception thresholds measured in a platform allowing specific and smooth motion profiles in 3 linear and 3 angular dimensions.
8. Gait and posture: functional gait assessment, postural sway in conditions providing accurate or conflicting sensory (e.g., vestibular, visual, proprioceptive) information.
9. Spatial navigation in real and virtual reality environments (e.g. Morris water maze, standardized clinical environment).
10. Monitoring of the autonomous nervous system: standard, non-invasive clinical investigations of cardiovascular, ophthalmic, secretory, or metabolic functions (e.g., blood pressure, heart rate, pupillary reflex).

Eligibility criteria: Inclusion Criteria:

* Patients implanted with a vestibular implant showing neither auditory function nor vestibular one.
* Control group of patients implanted with a cochlear implant and presenting a normal vestibular function.
* Control group of patients with bilateral vestibular loss.
* Control group of patients with unilateral vestibular loss and finally
* Control group of healthy subjects with normal auditory and vestibular functions.

All sujbects included in the study will be older than 18 years old.

Exclusion Criteria:

* Children
* Patients suffering from blindness,
* Patients suffering from major ophtalmologic damage
* Patients suffering from neurologic disorder.

Primary outcomes:
measure: Change in Vestibular Ocular Reflex (VOR) amplitude
timeFrame: Immediately after the vestibular electrodes are activated
measure: Change in Vestibular Ocular Reflex (VOR) threshold
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in pure tone audiometry measurements
timeFrame: Immediately after the cochlear and/or vestibular electrodes are activated
measure: Changes in speech audiometry measurements
timeFrame: Immediately after the cochlear and/or vestibular electrodes are activated
measure: Changes in logatomes test results
timeFrame: Immediately after the cochlear and/or vestibular electrodes are activated
measure: Changes in the Temporal Binding Window (TBW)
timeFrame: Immediately after the cochlear and/or vestibular electrodes are activated
measure: Changes in the Auditory and Vestibular evoked potentials (AEPs-VEPs)
timeFrame: Immediately after the cochlear and/or vestibular electrodes are activated
measure: Changes in the cortical and subcortical activity
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in the Vestibular Evoked Myogenic Potentials (VEMPs)
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in motion perception
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in gait dynamics while walking at different speeds
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in gait dynamics performing the Timed "Up & Go"
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in Functional Gait Assessment (FGA) performances
timeFrame: Immediately after the vestibular electrodes are activated
measure: Postural changes (sway threshold and/or amplitudes)
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in the dynamic visual acuity
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in angular error during a navigation task
timeFrame: Immediately after the vestibular electrodes are activated
measure: Changes in orthostatic hypotension test results (Shellong test)
timeFrame: Before and immediately after the vestibular electrodes are activated
measure: Changes in pupil size (pupillometry)
timeFrame: Before and immediately after the vestibular electrodes are activated
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Nils Guinand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boutabla A, Cavuscens S, Ranieri M, Cretallaz C, Kingma H, van de Berg R, Guinand N, Perez Fornos A. Simultaneous activation of multiple vestibular pathways upon electrical stimulation of semicircular canal afferents. J Neurol. 2020 Dec;267(Suppl 1):273-284. doi: 10.1007/s00415-020-10120-1. Epub 2020 Aug 10.
citation: Fornos AP, van de Berg R, Armand S, Cavuscens S, Ranieri M, Cretallaz C, Kingma H, Guyot JP, Guinand N. Cervical myogenic potentials and controlled postural responses elicited by a prototype vestibular implant. J Neurol. 2019 Sep;266(Suppl 1):33-41. doi: 10.1007/s00415-019-09491-x. Epub 2019 Aug 8.
citation: Perez Fornos A, Cavuscens S, Ranieri M, van de Berg R, Stokroos R, Kingma H, Guyot JP, Guinand N. The vestibular implant: A probe in orbit around the human balance system. J Vestib Res. 2017;27(1):51-61. doi: 10.3233/VES-170604.
citation: Cretallaz C, Boutabla A, Cavuscens S, Ranieri M, Nguyen TAK, Kingma H, Van De Berg R, Guinand N, Perez Fornos A. Influence of systematic variations of the stimulation profile on responses evoked with a vestibular implant prototype in humans. J Neural Eng. 2020 Jun 12;17(3):036027. doi: 10.1088/1741-2552/ab8342.
citation: Guinand N, Van de Berg R, Cavuscens S, Stokroos R, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez Fornos A. Restoring Visual Acuity in Dynamic Conditions with a Vestibular Implant. Front Neurosci. 2016 Dec 22;10:577. doi: 10.3389/fnins.2016.00577. eCollection 2016.
citation: Guinand N, Van de Berg R, Cavuscens S, Ranieri M, Schneider E, Lucieer F, Kingma H, Guyot JP, Perez Fornos A. The Video Head Impulse Test to Assess the Efficacy of Vestibular Implants in Humans. Front Neurol. 2017 Nov 14;8:600. doi: 10.3389/fneur.2017.00600. eCollection 2017.
citation: van de Berg R, Guinand N, Nguyen TA, Ranieri M, Cavuscens S, Guyot JP, Stokroos R, Kingma H, Perez-Fornos A. The vestibular implant: frequency-dependency of the electrically evoked vestibulo-ocular reflex in humans. Front Syst Neurosci. 2015 Jan 20;8:255. doi: 10.3389/fnsys.2014.00255. eCollection 2014.
citation: Nguyen TAK, Cavuscens S, Ranieri M, Schwarz K, Guinand N, van de Berg R, van den Boogert T, Lucieer F, van Hoof M, Guyot JP, Kingma H, Micera S, Perez Fornos A. Characterization of Cochlear, Vestibular and Cochlear-Vestibular Electrically Evoked Compound Action Potentials in Patients with a Vestibulo-Cochlear Implant. Front Neurosci. 2017 Nov 21;11:645. doi: 10.3389/fnins.2017.00645. eCollection 2017.
citation: Perez Fornos A, Guinand N, van de Berg R, Stokroos R, Micera S, Kingma H, Pelizzone M, Guyot JP. Artificial balance: restoration of the vestibulo-ocular reflex in humans with a prototype vestibular neuroprosthesis. Front Neurol. 2014 Apr 29;5:66. doi: 10.3389/fneur.2014.00066. eCollection 2014.
citation: Guinand N, van de Berg R, Cavuscens S, Stokroos RJ, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez-Fornos A. Vestibular Implants: 8 Years of Experience with Electrical Stimulation of the Vestibular Nerve in 11 Patients with Bilateral Vestibular Loss. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):227-240. doi: 10.1159/000433554. Epub 2015 Sep 15.
citation: Pelizzone M, Fornos AP, Guinand N, van de Berg R, Kos I, Stokroos R, Kingma H, Guyot JP. First functional rehabilitation via vestibular implants. Cochlear Implants Int. 2014 May;15 Suppl 1:S62-4. doi: 10.1179/1467010014Z.000000000165. No abstract available.