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临床试验/CTRI/2024/03/064818
CTRI/2024/03/064818尚未招募不适用

TO EVALUATE PROSPECTIVE AUDITORY CORTICAL ACTIVITY CHANGES ON FUNCTIONAL NEAR INFRARED SPECTROSCOPY IN PRELINGUAL PROFOUND SNHL PATIENTS UNDERGOING COCHLEAR IMPLANTATION

Mridul Sharma1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Evaluation of the prospective auditory cortical activity changes on fNIRS in prelingual profound SNHL patients undergoing cochlear implantation.

研究概览

简要总结

This study has been designed for the evaluation of the benefit of cochlear implantation by observing the changes of auditory cortical activity on fNIRS. Also the auditory cortical activation data can be used to compare the diverse factors hindering the outcomes after cochlear implantation. To prognosticate the cases post cochlear implantation and implement timely intervention if cortical activation is not upto the mark. A standardized test for prognosticating, evaluating and monitoring the cochlear implantee can be set up, if the study turns fruitful.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Pre-lingual bilateral profound sensory-neural hearing loss patients who are planned for cochlear implantation
  • Those who give consent
  • Those who have funds deposited in AIIMS for CI.

排除标准

  • Those who do not fit in inclusion criteria
  • Those who do not give consent.

结局指标

主要结局

Evaluation of the prospective auditory cortical activity changes on fNIRS in prelingual profound SNHL patients undergoing cochlear implantation.

时间窗: 1. pre cochlear implant | 2. 1 month post CI | 3. 6 month post CI

次要结局

  • Comparison of cortical activity changes on fNIRS with audioverbal outcome scores (CAP, SIR, MAIS)(1. pre cochlear implant)

研究者

发起方
Mridul Sharma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mridul Sharma

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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