Intraoperative Non-invasive Eye Movement Monitoring
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
- 否
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
Jamie J. Van Gompel
Associate Professor of Neurosurgery and Otolaryngology
Mayo Clinic
