Cochlear Implant Electrostimulation and the Influence on the Vestibular Organ

NCT05073796 | Completed

• 1 other identifier: 19-062
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Deafness Unilateral; Deafness, Bilateral; Deafness Congenital; Deafness, Acquired

Keywords

Deafness, Cochlea Implant

Outcome Measures

Primary Outcomes (1)

• 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.

  15 - 30 minutes

Study Arms (1)

Interventional arm

EXPERIMENTAL

Participants will receive the intervention as descibed in the respective section.

Device: Cochlea Implant

Interventions

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

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• Advanced Bionics: collaborator

Study Sites (1)

Klinik für Hals-Nasen-Ohrenheilkunde, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (5)

• 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.

  PMID: 29209162 BACKGROUND

• 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.

  PMID: 9473085 BACKGROUND

• 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.

  PMID: 29184530 BACKGROUND

• 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.

  PMID: 27291637 BACKGROUND

• 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.

  PMID: 25073175 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Unilateral; Hearing Loss, Bilateral; Deafness

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Martin Westhofen, Prof.Dr.med.

  Klinik für Hals- Nasen-Ohrenheilkunde, Uniklinik RWTH Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: October 11, 2021
• Study Start: September 9, 2020
• Primary Completion: January 9, 2021
• Study Completion: January 9, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)