Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

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

Detailed Description
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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.

Official Title
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Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

Conditions
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Deafness

Intervention / Treatment
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* Device: Electrical stimulation of cochlear nerve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Test of feasibility of electrical stimulation of the cochlear nerve with a conventional bipolar nerve stimulator
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vestibular schwannoma, cochlear nerve, auditory prosthesis