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Clinical Trials/NCT05248113
NCT05248113
Recruiting
N/A

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

University of California, Irvine1 site in 1 country8 target enrollmentJanuary 25, 2022
ConditionsDeafness

Overview

Phase
N/A
Intervention
Not specified
Conditions
Deafness
Sponsor
University of California, Irvine
Enrollment
8
Locations
1
Primary Endpoint
Auditory brainstem response
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 25, 2022
End Date
March 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harrison W Lin

Associate Professor

University of California, Irvine

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Women who are pregnant

Outcomes

Primary Outcomes

Auditory brainstem response

Time Frame: Recorded immediately during ongoing cochlear-nerve stimulation

Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve

Study Sites (1)

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