Electrical Stimulation of the Peripheral Vestibular System in Order to Develop a Vestibular Implant
NCT ID: NCT05246553
Last Updated: 2022-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2011-12-01
2023-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Modified cochlear implant recipients
Patients suffering from severe to profound hearing loss and severe bilateral vestibulopathy implanted with a modified cochlear implant providing 1 to 3 extracochlear electrodes implanted in proximity to the ampullary branches of the vestibular nerve (vestibular electrodes).
All experiments will be carried out while the vestibular electrodes are inactive, and while electrical stimulation is delivered to one or several vestibular electrodes, with and without concurrent cochlear stimulation.
Electrical stimulation of the vestibular system
Patients are implanted with a modified cochlear implant (CI) which comprises one to three extracochlear electrodes that are placed in the proximity of vestibular afferents (i.e., vestibular nerves or the ampullae of each semicircular canal), and an intracochlear array. Trains of electrical stimulation in the form of charge-balanced, biphasic pulses can be delivered through each of the implanted electrodes (cochlear or vestibular) and modulated via computer-controlled signals, audio signals (captured with a microphone) or by signals captured by head-mounted motion sensors.
Electrical stimulation of the auditory system
A cochlear implant (CI) is a device providing a sense of sound to a person who suffers from severe to profound sensorineural hearing loss. A CI comprises the following parts, a microphone (capturing the sound from the environment), a speech processor (receiving and encoding the sounds captured by the mircophone), a transmitter-receiver antenna pair (transmitting the information from the external to the implanted components), an implanted stimulator (converting the signal into a tonotopically arranged set of electrical pulses) and an electrode array inserted in the cochlea that will deliver the electrical pulses to different portions of the auditory nerve. Trains of electrical stimulation in the form of charge-balanced, biphasic pulses can be delivered through each of the electrodes in the cochlear array and modulated via computer-controlled signals or audio signals (captured with a microphone).
Cochlear Implant Patients (CI)
Unilateral or bilateral cochlear implant recipients with normal vestibular function documented within the clinical follow up of their cochlear implant, and without previous history of vestibular symptoms or complaints.
Electrical stimulation of the auditory system
A cochlear implant (CI) is a device providing a sense of sound to a person who suffers from severe to profound sensorineural hearing loss. A CI comprises the following parts, a microphone (capturing the sound from the environment), a speech processor (receiving and encoding the sounds captured by the mircophone), a transmitter-receiver antenna pair (transmitting the information from the external to the implanted components), an implanted stimulator (converting the signal into a tonotopically arranged set of electrical pulses) and an electrode array inserted in the cochlea that will deliver the electrical pulses to different portions of the auditory nerve. Trains of electrical stimulation in the form of charge-balanced, biphasic pulses can be delivered through each of the electrodes in the cochlear array and modulated via computer-controlled signals or audio signals (captured with a microphone).
Bilateral vestibulopathy Patients (BV)
Patients with documented diagnosis of bilateral vestibulopathy, according to the guidelines of the Barany society (Strupp et al., Journal of Vestibular Research, vol. 27, no. 4, pp. 177-189, 2017).
Bilateral vestibulopathy Patients (BV)
Diagnosis established on the basis of the consensus document of the Classification Committee of the Bárány Society (Strupp et al., Journal of Vestibular Research, vol. 27, no. 4, pp. 177-189, 2017).
Unilateral vestibulopathy Patients (UV)
Patients with documented diagnosis of unrecovered unilateral vestibulopathy, consistent with the current classification of vestibular disorders of the Bárány Society (www.jvr-web.org/ICVD.html).
Unilateral vestibulopathy Patients (UV)
Patients with documented diagnosis of unrecovered unilateral vestibulopathy, consistent with the current classification of vestibular disorders of the Bárány Society (www.jvr-web.org/ICVD.html).
Healthy Subjects (HS)
Normal auditory functiona and without previous auditory or vestibular symptoms or complaints. Normal vestibular function documented with the video-head impulse test.
No interventions assigned to this group
Interventions
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Electrical stimulation of the vestibular system
Patients are implanted with a modified cochlear implant (CI) which comprises one to three extracochlear electrodes that are placed in the proximity of vestibular afferents (i.e., vestibular nerves or the ampullae of each semicircular canal), and an intracochlear array. Trains of electrical stimulation in the form of charge-balanced, biphasic pulses can be delivered through each of the implanted electrodes (cochlear or vestibular) and modulated via computer-controlled signals, audio signals (captured with a microphone) or by signals captured by head-mounted motion sensors.
Electrical stimulation of the auditory system
A cochlear implant (CI) is a device providing a sense of sound to a person who suffers from severe to profound sensorineural hearing loss. A CI comprises the following parts, a microphone (capturing the sound from the environment), a speech processor (receiving and encoding the sounds captured by the mircophone), a transmitter-receiver antenna pair (transmitting the information from the external to the implanted components), an implanted stimulator (converting the signal into a tonotopically arranged set of electrical pulses) and an electrode array inserted in the cochlea that will deliver the electrical pulses to different portions of the auditory nerve. Trains of electrical stimulation in the form of charge-balanced, biphasic pulses can be delivered through each of the electrodes in the cochlear array and modulated via computer-controlled signals or audio signals (captured with a microphone).
Bilateral vestibulopathy Patients (BV)
Diagnosis established on the basis of the consensus document of the Classification Committee of the Bárány Society (Strupp et al., Journal of Vestibular Research, vol. 27, no. 4, pp. 177-189, 2017).
Unilateral vestibulopathy Patients (UV)
Patients with documented diagnosis of unrecovered unilateral vestibulopathy, consistent with the current classification of vestibular disorders of the Bárány Society (www.jvr-web.org/ICVD.html).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients suffering from blindness,
* Patients suffering from major ophtalmologic damage
* Patients suffering from neurologic disorder.
18 Years
ALL
Yes
Sponsors
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University of Geneva, Switzerland
OTHER
Maastricht University Medical Center
OTHER
Massachusetts Eye and Ear Infirmary
OTHER
Nils Guinand
OTHER
Responsible Party
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Nils Guinand
Principal Investigator
Principal Investigators
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Nils Guinand, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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Geneva University Hospitals
Geneva, , Switzerland
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NAC 11-080 CER 11-129
Identifier Type: -
Identifier Source: org_study_id
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