Tonotopische Cochlea-Stimulation Und Der Einfluss Auf Das Vestibularorgan
| Registry | NCT05073796 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, sequential, masking: none, basic science |
| Enrollment | 10 (Actual) |
| Sponsor | RWTH Aachen University (Other); collaborators: Advanced Bionics |
| Conditions | Deafness Unilateral, Deafness, Bilateral, Deafness Congenital, Deafness, Acquired |
| Interventions | Cochlea Implant (Device) |
| Dates | start 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 in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Deafness Unilateral All trials for Deafness, Bilateral All trials of Cochlea Implant
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Interventional arm | Experimental | Device: Cochlea Implant | Participants will receive the intervention as descibed in the respective section. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Klinik für Hals-Nasen-Ohrenheilkunde, University Hospital Aachen | Aachen, North Rhine-Westphalia | Germany |