Deafness UnilateralNCT05073796
Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ
A study testing Cochlea Implant in people with Deafness Unilateral and Deafness, Bilateral, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deafness Unilateral, Deafness, Bilateral, Deafness Congenital
- What is being tested?
- Cochlea Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 9 Sep 2020to 9 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Hals-Nasen-Ohrenheilkunde, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Tonotopische Cochlea-Stimulation Und Der Einfluss Auf Das Vestibularorgan
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.
Read the 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.
- Being tested
- Cochlea Implant
- Keywords
- Deafness, Cochlea Implant
- Medical subject headings
- Hearing Loss, Unilateral, Hearing Loss, Bilateral, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlea ImplantDevice
- 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
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Participants will receive the intervention as descibed in the respective section. Receives: Device: Cochlea Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 - 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start9 Sep 2020
- Primary completion9 Jan 2021
- Study completion9 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Deafness UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Bionics
- Responsible party
- Sponsor
- Investigators
- Martin Westhofen, Prof.Dr.med., Principal investigator, Klinik für Hals- Nasen-Ohrenheilkunde, Uniklinik RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073796
- Sponsor's protocol ID
- 19-062
- Status last verified
- Oct 2021
- First submitted
- 27 Nov 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29209162Bance 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.
PubMed 9473085Guinand 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.
PubMed 29184530Parkes 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.
PubMed 27291637Jiang 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.
PubMed 25073175
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tonotopische Cochlea-Stimulation Und Der Einfluss Auf Das Vestibularorgan
- ClinicalTrials.gov ID
- NCT05073796
- Acronym / sponsor ID
- 19-062
- Keywords
- Deafness, Cochlea Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Advanced Bionics
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Cochlea ImplantParticipants will receive the intervention as descibed in the respective section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Interventional arm |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Background: PubMed 29209162Nguyen 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.
- Background: PubMed 9473085Bance 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.
- Background: PubMed 29184530Guinand 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.
- Background: PubMed 27291637Parkes 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.
- Background: PubMed 25073175Jiang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Westhofen, Prof.Dr.med. principal investigator
Klinik für Hals- Nasen-Ohrenheilkunde, Uniklinik RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlea Implant in people with Deafness Unilateral and Deafness, Bilateral, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the subjective visual vertical (SVV) with tonotopic CI stimulation (time frame: 15 - 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05073796, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.