Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05248113
Status:
RECRUITING
Last Update Posted:
2022-12-01
First Post:
2022-02-09
Brief Title:
Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients VS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None