Using Electrocochleography to Guide Insertion of the Electrode Array During Cochlear Implantation of the Neuro Zti (eCoN)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Correlation coefficient between the eCochG trauma index (in µV) and the residual hearing (in dB HL).
研究概览
简要总结
The main objective of this study is to evaluate the correspondence between eCochG and residual hearing by adding two modifications. First, a novel technique for placing and maintaining the probe in place during the whole insertion will be used. Second, a new metric for estimating the eCochG response will be evaluated (eCochG trauma index). The secondary objective is to find other markers of the cochlear trauma insertion associated to eCochG measures. This will be used to evaluate to which extend a traumatic insertion will be deleterious for the patient's post-operative hearing, and ultimately to prevent trauma to the inner ear. Finally, the potential differences in cochlear trauma resulting of the electrode array insertion from two different surgery techniques will be investigated; Either using a manual insertion or using a robotic arm that will drive the insertion automatically.
详细描述
Main study procedures and assessments:
- Visit 1 (D-30+/-14) INCLUSION: subject information/consent, inclusion/exclusion criteria, CT-scan, Tonal audiometry
- Visit 2 (D0+/-14) COCHLEAR IMPLANT SURGERY: CT-scan, Intra-op eCochG, eCAP, Impedance
- Visit 3 (D+30+/-14) FOLLOW-UP 1 MONTH: Tonal audiometry, Impedance, Fitting maps
- Visit 4 (D+60+/-14) FOLLOW-UP 2 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes
- Visit 5 (D+90+/-14) FOLLOW-UP 3 MONTH: Tonal audiometry, Impedance, Fitting maps, Phonemes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •> or equal 18 years ;
- •Candidate for Neuro Zti EVO cochlear implant system, unilateral or bilateral recipient ;
- •Preoperative residual hearing with audiometric thresholds less or equal than 80 dB at 500 Hz, or higher frequencies
排除标准
- •Medical or psychological conditions which contraindicate surgery (e.g middle ear infection, tympanic membrane perforation) ;
- •Patient with a psychological or linguistic inability to understand the information sheet ;
- •Patient under legal protection or deprived of liberty
- •Patient included and participating to another trial.
结局指标
主要结局
Correlation coefficient between the eCochG trauma index (in µV) and the residual hearing (in dB HL).
时间窗: Through study completion, an average of 2 years
The eCochG trauma index correspond to electrophysiological changes of the cochlear response during the CI electrode insertion, and is calculated from the difference between post-insertion and pre-insertion eCochG measure (in µV). The hearing loss is calculated from the difference between the post-surgical and pre-surgical hearing thresholds (in dB HL). The correspondence is calculated from the correlation coefficient between the eCochG trauma index and the hearing loss. It is expected that a potential damage measured by the eCochG during the surgery have affected auditory threshold.
次要结局
- Significant decrease of eCochG trauma index (in µV) for electrode array insertion performed manually compared to robotic.(Through study completion, average of 2 years)
- Correlation coefficient between the eCochG trauma index (in nV) with the electrical charges (in nC) required to elicit eCAP threshold.(Through study completion, average of 2 years)
- Correlation coefficient between the eCochG trauma index (in nV) with impedance measurement (in Ω).(Through study completion, average of 2 years)
- Correlation coefficient between the eCochG trauma index (in nV) with fitting map electrical charges (in nC), and slopes of their growth functions.(Through study completion, average of 2 years)
- Correlation coefficient between the eCochG trauma index (in nV) with scores of phonemes discrimination (%).(Through study completion, average of 2 years)
- Correlation coefficient between the eCochG trauma index (in µV) and a misplacement of the electrode array inside the cochlea based on CT scan.(Through study completion, average of 2 years)