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

Sponsor
Oticon Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT02948790
Collaborator
(none)
17
Enrollment
4
Locations
2
Arms
23.9
Actual Duration (Months)
4.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Neuristim
  • Device: Cochlear implant
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study
Actual Study Start Date :
Apr 7, 2017
Actual Primary Completion Date :
Apr 3, 2019
Actual Study Completion Date :
Apr 3, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Wave V latency [perioperatively]

    Secondary Outcome Measures

    1. Complications [perioperatively, 15 days postoperatively]

    2. Impedance measurement [perioperatively]

    3. ergonomics of the Neuristim [perioperatively]

      satisfaction questionnaire

    4. Speech audiometry [3 months postoperatively]

      in quiet and in noise

    5. Pure tone audiometry [3 months postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Bordeaux - Pellegrin Bordeaux France
    2 University Hospital Grenoble - A. Michallon Grenoble France
    3 University Hospital Lyon - Edouard Herriot Lyon France
    4 University Hospital Pitié Salpétrière Paris France

    Sponsors and Collaborators

    • Oticon Medical

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Oticon Medical
    ClinicalTrials.gov Identifier:
    NCT02948790
    Other Study ID Numbers:
    • PIC_05
    First Posted:
    Oct 28, 2016
    Last Update Posted:
    Oct 20, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuroma
    Neuroma, Acoustic
    Hearing Loss
    Hearing Loss, Sensorineural

    Study Results

    No Results Posted as of Oct 20, 2021