NCT05073796

Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ

Tonotopische Cochlea-Stimulation Und Der Einfluss Auf Das Vestibularorgan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Deafness Unilateral
• Deafness, Bilateral
• Deafness Congenital
• Deafness, Acquired

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-01-09
• Completion: 2021-01-09
• First posted: 2021-10-11
• Last updated: 2021-10-11

Locations

1 site across 1 country: Germany