Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Last updated: November 28, 2022
Sponsor: University of California, Irvine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Deafness

Treatment

N/A

Clinical Study ID

NCT05248113
2017-3885
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Women who are pregnant

Study Design

Total Participants: 8
Study Start date:
January 25, 2022
Estimated Completion Date:
March 31, 2024

Study Description

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.

Connect with a study center

  • UC Irvine Health, Pavilion II

    Orange, California 92868
    United States

    Active - Recruiting

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