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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05248113
Other study ID # 2017-3885
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 25, 2022
Est. completion date March 2024

Study information

Verified date November 2022
Source University of California, Irvine
Contact Harrison W Lin, MD
Phone 714 456 5753
Email harriswl@hs.uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States UC Irvine Health, Pavilion II Orange California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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