Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
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
- 否
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
Harrison W Lin
Associate Professor
University of California, Irvine
