Clinical Trial Comparing Neurologic Development of Temporal Voice Area in Cochlear Implanted Deaf Infant and in Normally Hearing Infant.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 24 months of age.
研究概览
简要总结
Hypothesis At 12 months of age, the neurologic development of TVA of a non cochlear implanted profound congenital deaf infant would be different to the development of a normally hearing infant.
At 24 months of age, the neurologic development of TVA of deaf infant implanted before the age of 18 months would be similar to the development of a normally hearing infant.
Main aim The main aim of the research is to study, by means of functional near infrared spectroscopy (fNIRS), the neurologic development of the TVA at 24 months of age (+/- 1 month) in a group (n=40) of normally hearing infant and in a group (n=40) of profound congenital deaf children implanted before the age of 18 months.
Main outcome Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type. Comparison of the results between groups at 24 months of age +/- 1 month allows to analyse eventual differences.
Secondary aims and outcomes To study by means of functional near infrared spectroscopy the neurologic development of the temporal voice area at 12 months of age (+/- 1 month) in a group of normally hearing infant and in a group of profound congenital deaf infant wearing a standard hearing device between the age of 11 and 13 months and who will receive a cochlear implant between 12 and 18 months of age.
To study the association between fNIRS data and clinical data of the evaluation of comprehension of the spoken language at 24 months of age.
Methods Two groups of 40 infants matching in age will be constituted. Less than 13 months old children will be included during a medical consultation in the ENT department of Necker hospital after complete information of both parents. Written consent of both parents will be required. An audiophonological checking will be done.
Then a fNIRS examination will be programmed at the maternity of the Robert Debré hospital and done at the age of 12 months (+/- 1 month) and 24 months (+/-1 month). A fNIRS examination will be programmed at 36 months of age (+/- 1 month) for patinets included in the first year of the study.
This fNIRS examination measures the modifications in brain blood flow during the listening of human voice sound and environmental sound.
详细描述
One or two among a thousand new-born will require hearing device or cochlear implantation before the age of 4 years to correct a hearing loss. Without any appropriate hearing stimulation, some brain area, including temporal voice area (TVA), will remodel. But this remodeling process is a deleterious phenomenon in case of future cochlear implantation. Therefore it seems to be crucial to better understand the impact of hearing loss on neurologic development of TVA in infant.
Main aim and outcome:
Main aim of the research is to compare cortical activation in the TVA at 24 months of age (+/- 1 month), by means of the measure of hemoglobin and/or desoxyhemoglobin concentration in the TVA during listening of human voice sound compared to non-voice sound (environmental sounds) (fNIRS method):
- in normally hearing infants
- in profound congenital deaf infants who received a standard auditory device before the age of 10 months and who were implanted between 12 and 18 months of age.
Comparison of the results in these two groups at 24 months +/- 1 month will allow to evaluate the impact of hearing loss and of its rehabilitation by means of standard hearing device and then by cochlear implant on neurologic development of the TVA in infant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 24 months of age.
时间窗: 24 months of age
次要结局
- Measure and localization of an increase of brain blood flow during an auditory stimulation "voice" type compared to a stimulation "non-voice" type at 12 months of age.(12 months of age)
- Brain blood flow by means of fNIRS (Functional Near infrared Spectroscopy)(24 months of age)