Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

University of California Irvine (UCI)

Status: Enrolling

Conditions: Deafness

Treatments: Device: Electrical stimulation of cochlear nerve

Study type: Interventional

Funder types: Other

Identifiers

NCT05248113

2017-3885

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Intraoperative electrical stimulation of cochlear nerve

Experimental group

Description:

Electrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection.

Treatment:

Device: Electrical stimulation of cochlear nerve