Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Orange, California
Dates
study started
estimated completion
Principal Investigator
by Harrison M Lin, MDJohn C Middlebrooks, PhD

Description

Summary

This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.

Details

This is a feasibility study being conducted prior to development of a penetrating cochlear nerve stimulating electrode. Experiments will be conducted in patients who are undergoing surgery for resection of a vestibular schwannoma (VS). In the normal course of such a surgical procedure, the cochlear nerve is exposed and, in many cases, the cochlear nerve is resected or function of the cochlear nerve is otherwise disrupted. Typically, recording electrodes are placed on the scalp for the purpose of recording sound-evoked auditory brainstem responses (ABRs), which serve as a measure of the functional status of the cochlear nerve. In this intraoperative experimental procedure, a conventional bipolar nerve stimulating electrode will be placed in contact with the cochlear nerve and the nerve will be stimulated with electrical pulses. Activation of the auditory system by the electrical pulses will be evaluated by measurement of electrically-evoked ABRs, using the same scalp electrodes that are typically used for measurement of sound-evoked ABRs. The cochlear-nerve stimulating electrode will be in place only during the actual intraoperative test. No device will remain in the patient. The intraoperative experimental procedure is not intended to as a therapeutic measure for the patient's VS.

Keywords

Deafness, vestibular schwannoma, cochlear nerve, auditory prosthesis, Neurilemmoma, Neuroma, Acoustic, Electrical stimulation of cochlear nerve, Intraoperative electrical stimulation of cochlear nerve

Eligibility

You can join if…

Open to people ages 18-99

  • Adults with the diagnosis of unilateral or bilateral vestibular schwannoma proven on radiographic imaging.
  • Only patients with little or no hearing ability undergoing surgical resection of the tumor will be enrolled.

You CAN'T join if...

  • Women who are pregnant

Location

  • UC Irvine Health, Pavilion II accepting new patients
    Orange California 92868 United States

Lead Scientists at UC Irvine

  • Harrison M Lin, MD
    Associate Professor, Otolaryngology, School of Medicine. Authored (or co-authored) 127 research publications
  • John C Middlebrooks, PhD
    Professor, Otolaryngology, School of Medicine. Authored (or co-authored) 90 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT05248113
Study Type
Interventional
Participants
Expecting 8 study participants
Last Updated