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Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Primary Purpose

Deafness

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electrical stimulation of cochlear nerve

About this trial

This is an interventional device feasibility trial for Deafness focused on measuring vestibular schwannoma, cochlear nerve, auditory prosthesis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UC Irvine Health, Pavilion IIRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative electrical stimulation of cochlear nerve

Arm Description

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

Outcomes

Primary Outcome Measures

Auditory brainstem response

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05248113

First Posted

February 9, 2022

Last Updated

November 28, 2022

Sponsor

University of California, Irvine

1. Study Identification

Unique Protocol Identification Number

NCT05248113

Brief Title

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Official Title

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deafness

Keywords

vestibular schwannoma, cochlear nerve, auditory prosthesis

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Test of feasibility of electrical stimulation of the cochlear nerve with a conventional bipolar nerve stimulator

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intraoperative electrical stimulation of cochlear nerve

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Electrical stimulation of cochlear nerve

Intervention Description

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.

Primary Outcome Measure Information:

Title

Auditory brainstem response

Description

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

Time Frame

Recorded immediately during ongoing cochlear-nerve stimulation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Harrison W Lin, MD

Phone

714 456 5753

harriswl@hs.uci.edu

First Name & Middle Initial & Last Name or Official Title & Degree

John C Middlebrooks, PhD

Phone

949 910 0333

middlebj@hs.uci.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harrison M Lin, MD

Organizational Affiliation

University of California, Irvine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John C Middlebrooks, PhD

Organizational Affiliation

University of California, Irvine

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC Irvine Health, Pavilion II

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harrison W Lin, MD

Phone

714-456-5753

harriswl@hs.uci.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

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