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Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma

NCT ID: NCT02948790

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2019-04-03

Brief Summary

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The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.

Detailed Description

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Whatever the acoustic neuroma treatments, the patient risks a hearing loss. The global strategy of hearing care aims to preserve the quality of life and patient hearing. For severe to profound hearing loss and anatomical auditory nerve preservation, the cochlear implant is put forward compared to the auditory brainstem implant. Indeed, cochlear implant provides better speech outcomes. If cochlear implantation is not possible or no benefit for the patient, the brainstem implant is the most widely used. The Neuristim device is used to investigate the auditory nerve integrity following neuroma surgery or on an affected auditory nerve. The Neuristim is an intra-cochlear stimulator used in an intraoperative way. The intra-cochlear electrodes provide an electrical stimulation to auditory nerve fibers, and auditory nerve response measurements to these electrical stimulation are recorded and evaluated to determine the auditory nerve functionality. The Neuristim is a device for helping surgeons to choose the most appropriate implantable solution. 2 groups of patients will be involved in this study:

* a group of 17 patients with an acoustic neuroma or a past neuroma surgically removed or acoustic neuroma not requiring a surgery and with severe to profound hearing loss candidate for a cochlear implant or a auditory brainstem depending on the auditory nerve functionality,
* a group of 17 patients with severe to profound hearing loss candidate for a cochlear implant.

Conditions

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Hearing Loss, Cochlear Neurinoma of the Acoustic Nerve

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Neuristim

Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).

Group Type EXPERIMENTAL

Neuristim

Intervention Type DEVICE

Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode

Digisonic SP EVO cochlear implant

Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).

Group Type ACTIVE_COMPARATOR

Cochlear implant

Intervention Type DEVICE

Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode

Interventions

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Neuristim

Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode

Intervention Type DEVICE

Cochlear implant

Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode

Intervention Type DEVICE

Other Intervention Names

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Digisonic SP EVO

Eligibility Criteria

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Inclusion Criteria

* Must be 18 years or older
* Patient with an acoustic neuroma already surgically removed with associated hearing loss (experimental group),
* Patient with an acoustic neuroma programmed to be surgically removed and candidates for an implantable hearing rehabilitation solution (experimental group),
* Patient with an acoustic neuroma that not need to be removed and candidate for an implantable hearing rehabilitation solution (experimental group), or
* Typical patient candidate for a cochlear implant (control group)

Exclusion Criteria

* Cochlea malformation, cochlea ossification
* Vulnerable subject
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Vincent, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital University Lille-Roger Salengro

Locations

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University Hospital Bordeaux - Pellegrin

Bordeaux, , France

Site Status

University Hospital Grenoble - A. Michallon

Grenoble, , France

Site Status

University Hospital Lyon - Edouard Herriot

Lyon, , France

Site Status

University Hospital Pitié Salpétrière

Paris, , France

Site Status

Countries

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France

Related Links

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http://www.oticonmedical.com

oticon medical website

Other Identifiers

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PIC_05

Identifier Type: -

Identifier Source: org_study_id