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临床试验/NCT04987684
NCT04987684Unknown不适用

Objective Measures of Cochlear Implant Electrode Position and Function

Sophie McKenny1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Validation of extra cochlear electrodes

研究概览

简要总结

Recruit adult patients eligible for cochlear Implant surgery. During routine surgery monitor electrode placement with new 'SCINSEV' technique and complete 'PECAPs' on patient to identify if any of the electrodes have misplaced.

Follow up with patient after surgery for post operative appointment with same measurements.

详细描述

Cochlear implants (CIs) restore hearing to deaf patients by electrically stimulating the auditory nerve using an array of electrodes inserted into the cochlea (inner ear). All electrodes should be successfully inserted in the cochlea, with each electrode exciting a discrete range of auditory nerve fibers.

Our research investigates two exceptions to this ideal situation, both of which impair the participant's ability to clearly hear sounds such as speech. One exception occurs when some electrodes are located outside the cochlea, limiting the amount of information that is conveyed to the brain and potentially causing unwanted side effects.

Our research will identify these extra-cochlear electrodes during the CI operation, by stimulating each electrode in turn and recording from all other electrodes.

This "SCINSEV" technique then uses a sophisticated computational method to identify which if any electrodes are out of the cochlea. Even when all electrodes are in the cochlea, however, some may produce broad current spreads, which will "blur" the perception of sounds. Our second "PECAP" method measures these instances by stimulating pairs of electrodes and recording the neural responses. It also uses a new computational method, this time so as to calculate the neural spread from each electrode.

Both methods use fast, non-invasive, objective measurements that use the built-in capabilities of the implant .The interventions used are very similar to those employed in standard clinical practice, and the results will pave the way for better identification and management of poor hearing by CI patients

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Participant is willing or able to consent to participation in the study
  • •Meets normal candidacy requirements for cochlear implantation
  • •At least 18 years of age at time of consent being given
  • •Patent cochlea as verified by CT or MRI scan
  • •No additional complex needs that would prevent study procedures being followed
  • •Agreement to participate in the study

排除标准

  • •Using medication in a manner that might affect hearing levels

研究组 & 干预措施

Standard of Care

Other

干预措施: SCINSEV and PECAP (Diagnostic Test)

结局指标

主要结局

Validation of extra cochlear electrodes

时间窗: 12 months

Number of extra-cochlear electrodes obtained using our "SCINSEV" analysis correspond to the actual number of extra-cochlear electrodes observed during different stages of insertion.

次要结局

  • Pre and post op loudness comparison(12 months)

研究者

发起方
Sophie McKenny
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sophie McKenny

Clinical Researcher

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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