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临床试验/NCT05248113
NCT05248113招募中不适用

Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
8
试验地点
2
主要终点
Auditory brainstem response

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Women who are pregnant

结局指标

主要结局

Auditory brainstem response

时间窗: Recorded immediately during ongoing cochlear-nerve stimulation

Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harrison W Lin

Associate Professor

University of California, Irvine

研究点 (2)

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