Clinical trial NCT02948790: Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma
Official title: Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Cochlear
Neurinoma of the Acoustic Nerve
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2016-10-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wave V latency
timeFrame: perioperatively
Secondary outcomes:
measure: Complications
timeFrame: perioperatively, 15 days postoperatively
measure: Impedance measurement
timeFrame: perioperatively
measure: ergonomics of the Neuristim
timeFrame: perioperatively
measure: Speech audiometry
timeFrame: 3 months postoperatively
measure: Pure tone audiometry
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux - Pellegrin
city: Grenoble
country: France
facility: University Hospital Grenoble - A. Michallon
city: Lyon
country: France
facility: University Hospital Lyon - Edouard Herriot
city: Paris
country: France
facility: University Hospital Pitié Salpétrière
Study officials:
affiliation: Hospital University Lille-Roger Salengro
name: Christophe Vincent, MD
role: PRINCIPAL_INVESTIGATOR
References: