An interventional study of Cochlea Implant in Deafness Unilateral, Deafness, Bilateral and Deafness Congenital, sponsored by RWTH Aachen University. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-11.
Sponsored by RWTH Aachen University · Not applicable, Interventional, and Basic science
There is evidence that the sensor function of the utricle in patients with bilateral labyrinthine dysfunction (bilateral vestibulopathy) may improve balance under the influence of high frequency basal stimulation of the cochlea.
The aim of the study is to measure the possible co-stimulation of the utricle (which is determined by the SVV) by tonotopic (frequency-specific) cochlear stimulation and thus to objectify whether the stimulation of the auditory nerve in CI patients also leads to an unavoidable co-stimulation of the vestibular system.
The cochlea is tonotopically structured, i.e. certain frequencies are mapped on a specific part of the cochlea from basal to apical. It is not yet known whether tonotopically differentiated stimulation of the cochlea has an unavoidable side effect on other body systems, such as the vestibular organ. If the labyrinthine dysfunction occurs as a consequence of a CI implantation, this could in the future lead to the possibility of reducing vestibular complications after CI surgery by switching certain electrodes on or off.
In a first investigation phase, a conventional and already implanted CE-certified cochlear implant will be used. The aim of this project is to test certain tonotopic stimulus patterns that stimulate the cochlea by varying the volume within predefined settings. Thus, there is no misuse of the device and no change in performance attributes. Within the framework of the clinical project planned here, the testing of vestibular co-stimulation during normal cochlear stimulation via the basal, medial and apical electrodes of the CI electrode is planned. Under the influence of defined stimulation patterns, the assessment of the subjective visual vertical (SVV) in project participants will be investigated.
The influence of tonotopic stimulation on the SVV result will have a high priority.
609 studies on the registry are indexed under Deafness; 111 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 411 interventional studies indexed under Deafness.
Browse Deafness studies →RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Participants will receive the intervention as descibed in the respective section.
Device: Cochlea Implant
* examination and documentation of vital signs and concomitant medication * application of an cochlea implant loan processor (external body surface) with varying stimulus pattern for vestibular stimulation by means of basal, medial and apical electrodes * attraction of an special mask to determine the subjective visual vertical (SVV) * assessment of the vertical spatial axis with all electrodes turned off * assessment of the vertical spatial axis with all electrodes turned on * assessment of the vertical spatial axis while using basal (12-16) and medial (6-11) electrodes * assessment of the vertical spatial axis while using basal (12-16) and apical (1-5) electrodes * assessment of the vertical spatial axis while using medial (6-11) and apical (1-5) electrodes
Change of the subjective visual vertical (SVV) with tonotopic CI stimulation
The SVV is determined by wearing a special mask that prevents patients from seeing their spatial position. Instead, they see a light bar in the mask. The head is now tilted to the left and right. After adjusting the body position, the examiner asks to be told when the light bar is perceived to be vertical.
Time frame: 15 - 30 minutes
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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RWTH Aachen University