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Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05248113
Enrollment
8
Registered
2022-02-21
Start date
2022-01-25
Completion date
2024-03-31
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deafness

Keywords

vestibular schwannoma, cochlear nerve, auditory prosthesis

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.

Interventions

DEVICEElectrical 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.

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Auditory brainstem responseRecorded immediately during ongoing cochlear-nerve stimulationElectrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve

Countries

United States

Contacts

Primary ContactHarrison W Lin, MD
harriswl@hs.uci.edu714 456 5753
Backup ContactJohn C Middlebrooks, PhD
middlebj@hs.uci.edu949 910 0333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026