Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

NCT ID: NCT05248113

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2024-03-31

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.

Conditions

Deafness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Intraoperative electrical stimulation of cochlear nerve

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

Group Type: EXPERIMENTAL

Electrical stimulation of cochlear nerve

Intervention Type: DEVICE

Intraoperative electrical stimulation of the cochlear nerve in patients undergoing surgery for resection of vestibular schwannoma. Activation of the auditory system monitored with scalp recording of auditory brainstem response.

Interventions

Electrical stimulation of cochlear nerve

Intraoperative electrical stimulation of the cochlear nerve in patients undergoing surgery for resection of vestibular schwannoma. Activation of the auditory system monitored with scalp recording of auditory brainstem response.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Harrison W Lin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harrison M Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

John C Middlebrooks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

UC Irvine Health, Pavilion II

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Harrison W Lin, MD

Role: CONTACT

harriswl@hs.uci.edu

714 456 5753

John C Middlebrooks, PhD

Role: CONTACT

middlebj@hs.uci.edu

949 910 0333

Facility Contacts

Harrison W Lin, MD

Role: primary

harriswl@hs.uci.edu

714-456-5753

Other Identifiers

2017-3885

Identifier Type: -

Identifier Source: org_study_id