Loading clinical trials...
Loading clinical trials...
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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Geneva University Hospitals
Geneva, Switzerland
Start Date
December 1, 2011
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
February 18, 2022
52
ESTIMATED participants
Electrical stimulation of the vestibular system
PROCEDURE
Electrical stimulation of the auditory system
PROCEDURE
Bilateral vestibulopathy Patients (BV)
DIAGNOSTIC_TEST
Unilateral vestibulopathy Patients (UV)
DIAGNOSTIC_TEST
Lead Sponsor
Nils Guinand
Collaborators
NCT05674786
NCT06229717
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions