Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ
Primary Purpose
Deafness Unilateral, Deafness, Bilateral, Deafness Congenital
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cochlea Implant
Sponsored by
About this trial
This is an interventional basic science trial for Deafness Unilateral focused on measuring Deafness, Cochlea Implant
Eligibility Criteria
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
Sites / Locations
- Klinik für Hals-Nasen-Ohrenheilkunde, University Hospital Aachen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional arm
Arm Description
Participants will receive the intervention as descibed in the respective section.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05073796
First Posted
November 27, 2020
Last Updated
October 8, 2021
Sponsor
RWTH Aachen University
Collaborators
Advanced Bionics
1. Study Identification
Unique Protocol Identification Number
NCT05073796
Brief Title
Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ
Official Title
Tonotopische Cochlea-Stimulation Und Der Einfluss Auf Das Vestibularorgan
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
January 9, 2021 (Actual)
Study Completion Date
January 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
Collaborators
Advanced Bionics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness Unilateral, Deafness, Bilateral, Deafness Congenital, Deafness, Acquired
Keywords
Deafness, Cochlea Implant
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Participants will receive the intervention as descibed in the respective section.
Intervention Type
Device
Intervention Name(s)
Cochlea Implant
Intervention Description
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 Outcome Measure Information:
Title
Change of the subjective visual vertical (SVV) with tonotopic CI stimulation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Westhofen, Prof.Dr.med.
Organizational Affiliation
Klinik für Hals- Nasen-Ohrenheilkunde, Uniklinik RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Hals-Nasen-Ohrenheilkunde, University Hospital Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29209162
Citation
Nguyen TAK, Cavuscens S, Ranieri M, Schwarz K, Guinand N, van de Berg R, van den Boogert T, Lucieer F, van Hoof M, Guyot JP, Kingma H, Micera S, Perez Fornos A. Characterization of Cochlear, Vestibular and Cochlear-Vestibular Electrically Evoked Compound Action Potentials in Patients with a Vestibulo-Cochlear Implant. Front Neurosci. 2017 Nov 21;11:645. doi: 10.3389/fnins.2017.00645. eCollection 2017.
Results Reference
background
PubMed Identifier
9473085
Citation
Bance ML, O'Driscoll M, Giles E, Ramsden RT. Vestibular stimulation by multichannel cochlear implants. Laryngoscope. 1998 Feb;108(2):291-4. doi: 10.1097/00005537-199802000-00025.
Results Reference
background
PubMed Identifier
29184530
Citation
Guinand N, Van de Berg R, Cavuscens S, Ranieri M, Schneider E, Lucieer F, Kingma H, Guyot JP, Perez Fornos A. The Video Head Impulse Test to Assess the Efficacy of Vestibular Implants in Humans. Front Neurol. 2017 Nov 14;8:600. doi: 10.3389/fneur.2017.00600. eCollection 2017.
Results Reference
background
PubMed Identifier
27291637
Citation
Parkes WJ, Gnanasegaram JJ, Cushing SL, McKnight CL, Papsin BC, Gordon KA. Vestibular evoked myogenic potential testing as an objective measure of vestibular stimulation with cochlear implants. Laryngoscope. 2017 Feb;127(2):E75-E81. doi: 10.1002/lary.26037. Epub 2016 Jun 12.
Results Reference
background
PubMed Identifier
25073175
Citation
Jiang D, Cirmirakis D, Demosthenous A. A vestibular prosthesis with highly-isolated parallel multichannel stimulation. IEEE Trans Biomed Circuits Syst. 2015 Feb;9(1):124-37. doi: 10.1109/TBCAS.2014.2323310. Epub 2014 Jul 25.
Results Reference
background
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Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ
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