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Completed

NCT Number: NCT02948790

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

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.

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Key information

Conditions

Hearing Loss, Cochlear Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neurinoma of the Acoustic Nerve Neuroectodermal Tumors Neuroendocrine Tumors Neurologic Manifestations Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Retrocochlear Diseases Sensation Disorders Signs and Symptoms Vestibulocochlear Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bordeaux - Pellegrin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuristim

Device

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

Cochlear Implant

Device

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

Other names: Digisonic SP EVO

Primary outcomes

  1. Wave V latency

    Time frame: perioperatively

Secondary outcomes

  1. Complications

    Time frame: perioperatively, 15 days postoperatively

  2. Impedance measurement

    Time frame: perioperatively

  3. ergonomics of the Neuristim

    Time frame: perioperatively

    satisfaction questionnaire

  4. Speech audiometry

    Time frame: 3 months postoperatively

    in quiet and in noise

  5. Pure tone audiometry

    Time frame: 3 months postoperatively

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

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

Acronym: NeuriStim

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 28, 2016
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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