Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Deafness
• Intervention / Treatment: Device: Electrical stimulation of 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 Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harrison W Lin, MD; Phone Number: 714 456 5753; Email: harriswl@hs.uci.edu
• Study Contact Backup: Name: John C Middlebrooks, PhD; Phone Number: 949 910 0333; Email: middlebj@hs.uci.edu

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • UC Irvine Health, Pavilion II
      • Contact: Harrison W Lin, MD; Phone Number: 714-456-5753; Email: harriswl@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative electrical stimulation of cochlear nerve; Electrical stimulation of the cochlear nerve will be tested intraoperatively in patients undergoing vestibular schwannoma resection.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auditory brainstem response	Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve	Recorded immediately during ongoing cochlear-nerve stimulation

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Harrison M Lin, MD, University of California, Irvine; Principal Investigator: John C Middlebrooks, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: vestibular schwannoma; cochlear nerve; auditory prosthesis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Otorhinolaryngologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Ear Diseases; Nervous System Neoplasms; Cranial Nerve Diseases; Sensation Disorders; Neuroendocrine Tumors; Hearing Disorders; Nerve Sheath Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Neoplasms; Neuroma; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Hearing Loss; Deafness; Neurilemmoma; Neuroma, Acoustic
• Other Study ID Numbers: 2017-3885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No