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

October 13, 2021 updated by: Oticon Medical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • University Hospital Bordeaux - Pellegrin
      • Grenoble, France
        • University Hospital Grenoble - A. Michallon
      • Lyon, France
        • University Hospital Lyon - Edouard Herriot
      • Paris, France
        • University Hospital Pitié Salpétrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuristim
Electrical stimulation with the Neuristim and auditory nerve electrical response measurements (wave V).
Device: Neuristim
Stimulation at high, medium and low intensity on apical, medial and basal Neuristim electrode
Active Comparator: Digisonic SP EVO cochlear implant
Electrical stimulation with the patient's cochlear implant and auditory nerve electrical response measurements (wave V).
Device: Cochlear implant
Stimulation at high, medium and low intensity on apical, medial and basal Cochlear implant electrode
Other Names:
  • Digisonic SP EVO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wave V latency
Time Frame: perioperatively
perioperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: perioperatively, 15 days postoperatively
perioperatively, 15 days postoperatively
Impedance measurement
Time Frame: perioperatively
perioperatively
ergonomics of the Neuristim
Time Frame: perioperatively
satisfaction questionnaire
perioperatively
Speech audiometry
Time Frame: 3 months postoperatively
in quiet and in noise
3 months postoperatively
Pure tone audiometry
Time Frame: 3 months postoperatively
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticon Medical

Investigators

  • Principal Investigator: Christophe Vincent, MD, Hospital University Lille-Roger Salengro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2017

Primary Completion (Actual)

April 3, 2019

Study Completion (Actual)

April 3, 2019

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIC_05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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