Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Not Applicable

Recruiting

• Conditions: Deafness
• Interventions: Device: Electrical stimulation of cochlear nerve

• Registration Number: NCT05248113
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2022-01-25
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-12-01
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative electrical stimulation of cochlear nerve	Electrical stimulation of cochlear nerve	Electrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection.

Primary Outcome Measures

Name	Time	Method
Auditory brainstem response	Recorded immediately during ongoing cochlear-nerve stimulation	Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve

Trial Locations

Locations (1)

UC Irvine Health, Pavilion II; 🇺🇸 Orange, California, United States