Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Preschool Language Scales, Fifth Edition (PLS-5)
研究概览
简要总结
The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children's language by using predictive models to enable a custom "predict to prescribe" approach to intervene with more effective behavioral therapy for children at risk to develop poorer language. The investigators previously developed models for short term language outcome of English-learning implanted children. The aims of this study are to 1. Develop models able to predict long term outcome for English- learning and Spanish-learning children; and 2. To evaluate whether English-learning children predicted to achieve lower language based on the investigators' previously constructed models can demonstrate significant gains from Parent Implemented Communication Treatment (PICT). PICT is an intensive parent education program about strategies to improve children's communication.
详细描述
Arm1: Non-treatment Model Building. Up to 700 children will be recruited from 5 cochlear implant programs in the United States. Children will be enrolled and followed for up to four years after implantation. Study information will be obtained from each child's medical record before and after implantation including cause of hearing loss, general health, language and communication history, family history, cochlear implant device and surgery. Audiological information before and after implantation will be collected from routine visits that are part of cochlear implant candidacy evaluation and audiology evaluations after implantation. This includes audiology evaluations after activation of the cochlear implant that take place at around 6, 12, 18, 24, 36 and/or 48 months. Pre-surgical MRI done at each participating site as part of routine pre-operative evaluation will also be collected for analysis. If enrolled into the study at Lurie Children's Hospital of Chicago before the pre-surgical MRI is done, the parent or guardian will have the option to have their child undergo additional research scans during the pre-surgical MRI.
Parents will be asked to complete baseline and follow-up surveys. The surveys will ask about family demographic and health information, language exposure in the home, therapy and school services, and language and communication ability of the child. Parental surveys will be readministered at about 12-month intervals after the child's device is turned on. In addition, surveys about the child's cognition will be sent to parents after their child has used their implant for one and two years. Surveys will be offered online by a secure link provided during clinical visits, emailed after the visit or sent by MyChart to the parent/guardian for completion at home.
An in-person research-only speech and language evaluation will be done at about one-year intervals after initial implantation during each year the child is enrolled in the study. The evaluation will take less than two hours.
Arm 2: Experimental: Communication Treatment is terminated. Study#372634 (the human subjects study record) to be removed/terminated in ASSIST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with sensorineural hearing loss who meet clinical criteria for cochlear implantation in both ears who meet the following age criteria at time cochlear implant evaluation begins:
- •Age 5 years and under.
- •English or Spanish as the dominant language.
- •English or Spanish dominant language in the home.
- •Inclusion Criteria (Arm 2):
- •Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation
- •English dominant spoken language by family
- •Age at implantation of 36 months and younger when treatment begins
- •Parent or caregiver that is willing to participate who understands spoken English
- •Child is exposed to spoken language by at least one parent (total communication or auditory/oral) in the home
排除标准
- •Severe motor and /or cognitive disability that would preclude evaluation of progress
- •Limited electrode insertion likely to significantly impact development of speech perception
- •Hearing loss due to bacterial meningitis
- •Neither English or Spanish as the dominant family language in the home
- •Exclusion Criteria (Arm 2):
- •Severe motor and /or cognitive disability that would preclude evaluation of progress
- •Limited electrode insertion likely to significantly impact development of speech perception
- •Hearing loss due to bacterial meningitis
- •Dominant language other than English
- •Diagnoses or medical conditions expected to impact language development independent of hearing loss
- •Cochlear nerve deficiency in implanted ears or severe cochlear malformation
- •Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.
- •Child with more than two months CI experience prior to start of treatment
研究组 & 干预措施
Communication Treatment
Terminated
干预措施: Parent-Implemented Communication Treatment (Behavioral)
Non-treatment Model Building
结局指标
主要结局
Preschool Language Scales, Fifth Edition (PLS-5)
时间窗: At 48 months after cochlear implant activation
A standardized measure of auditory comprehension and expressive communication in children. Standard scores are obtained which are then translated to percentiles, and age equivalents. Higher standard scores indicate better performance.
Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
时间窗: At 48 months after cochlear implant activation
An individually administered, norm-referenced assessment of how well a person can name objects, actions, or concepts presented in full-color pictures. Raw scores are obtained which are then translated to standard scores, percentiles, and age equivalents. Both higher standard scores and raw scores indicate better performance.
MacArthur-Bates Communicative Development Inventory (CDI)
时间窗: At 48 months after cochlear implant activation
A set of online parent report intruments that evaluate children's early speech and langauge development. Standard scores are based on percentiles for age and sex and range from 1 to 99th percentile. Higher standard scores indicate better performance.
次要结局
- Behavior Rating Inventory of Executive Function (BRIEF)(At 24 months after cochlear implant activation)
- Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)(At 24 months after cochlear implant activation)
- Pediatric Minimum Speech Test Battery (PMSTB)(At 48 months after cochlear implant activation)
研究者
Nancy Young, MD
Head, Section of Otology/Neurotology and Medical Director, Audiology & Cochlear Implant Programs
Ann & Robert H Lurie Children's Hospital of Chicago