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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Oticon Medical

Current Primary Outcome: Wave V latency [ Time Frame: perioperatively ]

Original Primary Outcome: Wave V latency [ Time Frame: peroperatively ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Complications [ Time Frame: peroperatively, 15 days postoperatively ]
  • Impedance measurement [ Time Frame: peroperatively ]
  • ergonomics of the Neuristim [ Time Frame: peroperatively ]
    satisfaction questionnaire
  • Speech audiometry [ Time Frame: 3 months postoperatively ]
    in quiet and in noise
  • Pure tone audiometry [ Time Frame: 3 months postoperatively ]


Information By: Oticon Medical

Dates:
Date Received: October 26, 2016
Date Started: March 2017
Date Completion: May 2019
Last Updated: February 24, 2017
Last Verified: October 2016