Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Deafness Clinical Trial

Official title:

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248113
• Other study ID #: 2017-3885
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Deafness
• Neurilemmoma
• Neuroma, Acoustic

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