Skip to main content
OpenTrials
Completed

NCT Number: NCT05073796

Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deafness Unilateral Deafness Deafness Congenital Deafness, Acquired Deafness, Bilateral Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Bilateral Hearing Loss, Unilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Hals-Nasen-Ohrenheilkunde, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • uni- or bilaterally deafened and deaf patients with cochlear implants (one- or two- sided) from Advanced Bionics (AB), model HiRes 90K and newer
  • majority
  • given informed consent
  • legally competent and mentally able to follow the instructions of the personnel

Exclusion criteria

  • unsuccessful CI implantation (device or electrode defects, incomplete electrode array insertion, missing neuronal stimulus responses)
  • pregnant and/or breastfeeding women
  • severe pre- or concomitant disease or reduced general ground condition, so that an outpatient presentation in the ENT polyclinic is not possible
  • life expectancy of less than six months
  • the patient has received a study medication within the last 30 days within the framework of another study
  • simultaneous participation in another clinical intervention study
  • anticipated lack of compliance
  • alcohol or drug abuse
  • the patient is placed in an institution by order of the authorities or court
  • patients who are in a dependent or employed relationship with the sponsor, investigator, or their deputy

Treatment and study plan

Cochlea Implant

Device
  • 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

Primary outcomes

  1. Change of the subjective visual vertical (SVV) with tonotopic CI stimulation

    Time frame: 15 - 30 minutes

    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.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • Advanced Bionics

Registry information

Official study title

Tonotopische Cochlea-Stimulation Und Der Einfluss Auf Das Vestibularorgan

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.