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

Not Applicable

Completed

• Conditions: Hearing Loss, Cochlear; Neurinoma of the Acoustic Nerve
• Interventions: Device: Cochlear implant; Device: Neuristim

• Registration Number: NCT02948790
• Lead Sponsor: Oticon Medical

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Study Start: 2017-04-07
• Primary Completion: 2019-04-03
• Study Completion: 2019-04-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digisonic SP EVO cochlear implant	Cochlear implant	Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).
Neuristim	Neuristim	Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).

Primary Outcome Measures

Name	Time	Method
Wave V latency	perioperatively

Secondary Outcome Measures

Name	Time	Method
Complications	perioperatively, 15 days postoperatively
Impedance measurement	perioperatively
ergonomics of the Neuristim	perioperatively	satisfaction questionnaire
Speech audiometry	3 months postoperatively	in quiet and in noise
Pure tone audiometry	3 months postoperatively

Trial Locations

Locations (4)

University Hospital Bordeaux - Pellegrin; 🇫🇷 Bordeaux, France

University Hospital Lyon - Edouard Herriot; 🇫🇷 Lyon, France

University Hospital Pitié Salpétrière; 🇫🇷 Paris, France

University Hospital Grenoble - A. Michallon; 🇫🇷 Grenoble, France