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临床试验/NCT03046615
NCT03046615已完成不适用

Intraoperative Non-invasive Eye Movement Monitoring

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
3
试验地点
1
主要终点
Number of subjects with greater than 95% concordance in signal between the standard needles and EEG electrode patch

研究概览

简要总结

For procedures involving proximity to the nerves responsible for eye movement, the need to monitor eye movement exists. The current solution is to place needles in the muscles surrounding the eye. The Investigators have invented a non-invasive electrode and software designed to monitor eye movements non-invasively. The electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects the horizontal and vertical movements of the eye. The Investigators would like to prove efficacy compared to the standard monitoring.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Subject will be undergoing surgery involved of the nerves controlling the eye

排除标准

  • 未提供

结局指标

主要结局

Number of subjects with greater than 95% concordance in signal between the standard needles and EEG electrode patch

时间窗: approximately 30 minutes

The current method of measuring eye movement is to place needles in the muscles surrounding the eye. For the non-invasive method, the electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects horizontal and vertical movements of the eye. The signal comparison for the two methods would be a biphasic dipole representing eye movements compared to the compound muscle action potential of the invasive method.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie J. Van Gompel

Associate Professor of Neurosurgery and Otolaryngology

Mayo Clinic

研究点 (1)

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