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Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ

NCT05073796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-10-11

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Advanced Bionics

    collaborator INDUSTRY

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Martin Westhofen, Prof.Dr.med. · Klinik für Hals- Nasen-Ohrenheilkunde, Uniklinik RWTH Aachen

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2021-01-09
Completion
2021-01-09

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05073796 on ClinicalTrials.gov