Changes in the Threshold of Electrically Evoked Compound Action Potential in Children Following Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Changes in threshold of ECAP after cochlear implantation.
研究概览
简要总结
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, after 4 weeks( at switch on), after 3months and 6 months following cochlear implantation.
详细描述
After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).This ECAP is measured intra operatively, 4 weeks(at switch on) and after 3months and 6 months following cochlear implantation. Neural Response Telemetry (NRT) is a quick and non-invasive way of recording ECAP of the peripheral auditory nerves in-situ. It gives clinicians valuable information for programming the T- (Threshold) and C-(Comfort) - levels of the recipient's speech processor map. Intraoperative NRT in conjunction with electrode impedance data can help indicate the integrity of the implanted electrodes and the electrode/auditory nerve interface, confirming that the implant is functioning correctly intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children between 1 and 6 years of age undergoing cochlear implantation in JIPMER during the study period.
排除标准
- •Incomplete electrode array insertion.
结局指标
主要结局
Changes in threshold of ECAP after cochlear implantation.
时间窗: during implantation, at switch on( 4 weeks), after 3months and 6months.
To evaluate changes in threshold of ECAP during cochlear implantation, at switch on( 4 weeks), after 3 months and 6 months following cochlear implantation.
次要结局
- Correlate amplitude of ECAP with cochlear nerve diameter measured pre-operatively.(2 mins)
- Correlate the amplitude of ECAP with T & C levels.(2 years)
研究者
Dr. Aparna Das
JUNIOR RESIDENT
Jawaharlal Institute of Postgraduate Medical Education & Research