Clinical trial NCT05962359: Neural Prediction to Enhance Language
Official title: Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bilateral Sensorineural Hearing Loss
Speech and Language Development Delay Due to Hearing Loss
Social Communication
Keywords: Hearing Loss
Children
Parent-mediated intervention
Language prediction
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: Northwestern University
name: University of North Carolina, Chapel Hill
name: University of Southern California
name: University of Miami
name: The University of Texas at Dallas
First posted: 2023-07-27
Enrollment: 700
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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: Communication Treatment. In addition to all of the study procedures described above for Arm1, at only Lurie Children's Hospital of Chicago, 10 children will be enrolled in each of four years who meet additional inclusion criteria. Children enrolled in this arm will receive Parent Implemented Communication Treatment (PICT). PICT involves training parents to use communication skills to support development of their child's language. PICT will consist of one-hour weekly sessions for about six months provided virtually by a secure video chat system such as Zoom. The child and parent/caregiver will both participate in each weekly session. In addition, parent and child social interactions will be evaluated by video chat each month for six months and then annually for two years. The parent and child social interaction evaluation will take less than 15 minutes. Children who receive PICT will continue to receive all other therapies. In other words, no therapies will be discontinued during the time children are receiving PICT.

Eligibility criteria: Inclusion Criteria (Arm 1):

1. 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.
2. English or Spanish dominant language in the home.

Inclusion Criteria (Arm 2):

1. Children with bilateral sensorineural hearing loss who meet clinical criterial for cochlear implantation
2. English dominant spoken language by family
3. Age at implantation of 36 months and younger when treatment begins
4. Parent or caregiver that is willing to participate who understands spoken English
5. Child is exposed to spoken language by at least one parent (total communication or auditory/oral) in the home

Exclusion Criteria (Arm 1):

1. Severe motor and /or cognitive disability that would preclude evaluation of progress
2. Limited electrode insertion likely to significantly impact development of speech perception
3. Hearing loss due to bacterial meningitis
4. Neither English or Spanish as the dominant family language in the home

Exclusion Criteria (Arm 2):

1. Severe motor and /or cognitive disability that would preclude evaluation of progress
2. Limited electrode insertion likely to significantly impact development of speech perception
3. Hearing loss due to bacterial meningitis
4. Dominant language other than English
5. Diagnoses or medical conditions expected to impact language development independent of hearing loss
6. Cochlear nerve deficiency in implanted ears or severe cochlear malformation
7. Children already having spoken language who score better than 25th percentile on the Words and Sentences portion of the CDI language evaluation.
8. Child with more than two months CI experience prior to start of treatment

Primary outcomes:
measure: Preschool Language Scales, Fifth Edition (PLS-5)
timeFrame: At 12 months after cochlear implant activation
measure: Preschool Language Scales, Fifth Edition (PLS-5)
timeFrame: At 24 months after cochlear implant activation
measure: Preschool Language Scales, Fifth Edition (PLS-5)
timeFrame: At 36 months after cochlear implant activation
measure: Preschool Language Scales, Fifth Edition (PLS-5)
timeFrame: At 48 months after cochlear implant activation
measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
timeFrame: At 12 months after cochlear implant activation
measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
timeFrame: At 24 months after cochlear implant activation
measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
timeFrame: At 36 months after cochlear implant activation
measure: Expressive One-Word Picture Vocabulary Test, Fourth Edition (EOWPVT-4)
timeFrame: At 48 months after cochlear implant activation
measure: MacArthur-Bates Communicative Development Inventory (CDI)
timeFrame: At 12 months after cochlear implant activation
measure: MacArthur-Bates Communicative Development Inventory (CDI)
timeFrame: At 24 months after cochlear implant activation
measure: MacArthur-Bates Communicative Development Inventory (CDI)
timeFrame: At 36 months after cochlear implant activation
measure: MacArthur-Bates Communicative Development Inventory (CDI)
timeFrame: At 48 months after cochlear implant activation
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: At 12 months after cochlear implant activation
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: At 24 months after cochlear implant activation
measure: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
timeFrame: At 12 months after cochlear implant activation
measure: Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P)
timeFrame: At 24 months after cochlear implant activation
measure: Pediatric Minimum Speech Test Battery (PMSTB)
timeFrame: At 6 months after cochlear implant activation
measure: Pediatric Minimum Speech Test Battery (PMSTB)
timeFrame: At 12 months after cochlear implant activation
measure: Pediatric Minimum Speech Test Battery (PMSTB)
timeFrame: At 18 months after cochlear implant activation
measure: Pediatric Minimum Speech Test Battery (PMSTB)
timeFrame: At 24 months after cochlear implant activation
measure: Pediatric Minimum Speech Test Battery (PMSTB)
timeFrame: At 36 months after cochlear implant activation
measure: Pediatric Minimum Speech Test Battery (PMSTB)
timeFrame: At 48 months after cochlear implant activation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Nancy M Young, MD
role: PRINCIPAL_INVESTIGATOR
References: