Actively Recruiting
Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant
Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-08-05
700
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
Ann & Robert H Lurie Children's Hospital of Chicago
Lead Sponsor
C
Chinese University of Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying children with bilateral sensorineural hearing loss who receive cochlear implants. The study aims to develop brain imaging-based models that can predict long-term language outcomes for children who speak English or Spanish. Additionally, the research evaluates whether an intensive parent education program called Parent Implemented Communication Treatment (PICT) helps improve language skills in English-speaking children predicted to have lower language development. The overall goal is to tailor early interventions to better support children's language growth after cochlear implantation. The study has two parts. In the first, up to 700 children across five U.S. cochlear implant programs will be followed for up to four years after implantation. Medical records, audiological data, and pre-surgical brain scans will be collected, along with annual speech and language evaluations and parent surveys about language exposure and cognition. In the second part, at one hospital site, smaller groups of English-speaking children under 3 years old will receive PICT, which involves weekly one-hour virtual sessions with parents and children for about six months. Parent-child social interactions will also be assessed monthly during treatment and annually for two years. Participants will attend regular evaluations including speech and language testing, surveys, and video assessments of communication skills. Researchers will measure language abilities using tools like the Preschool Language Scales and vocabulary tests at multiple points up to 48 months after implant activation. The study also tracks executive function and speech test batteries over time. Families will be engaged via online surveys and video sessions, and children will continue any other therapies during the study. Total participation may last up to four years after the implant is activated.
CONDITIONS
Brief Title
Neural Prediction to Enhance Language
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with bilateral sensorineural hearing loss who meet clinical criteria for cochlear implantation
- Age 5 years and under at cochlear implant evaluation start
- English or Spanish is the dominant language spoken at home
- For treatment group: English dominant spoken language by family
- For treatment group: Age at implantation of 36 months or younger when treatment begins
- For treatment group: Parent or caregiver willing to participate and understands spoken English
- For treatment group: Child exposed to spoken language by at least one parent in the home
You will not qualify if you...
- Severe motor and/or cognitive disability that would prevent evaluation of progress
- Limited electrode insertion likely to significantly impact speech perception development
- Hearing loss caused by bacterial meningitis
- Neither English nor Spanish is the dominant family language at home
- For treatment group: Dominant language other than English
- For treatment group: Medical conditions expected to impact language development independent of hearing loss
- For treatment group: Cochlear nerve deficiency in implanted ears or severe cochlear malformation
- For treatment group: Children already having spoken language who score above the 25th percentile on the Words and Sentences portion of the CDI language evaluation
- For treatment group: Child with more than two months of cochlear implant experience prior to treatment start
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Variable prior to implantation
Participants undergo routine pre-operative evaluations including audiology tests and pre-surgical MRI as part of cochlear implant candidacy.
1 to 2 visits depending on timing of evaluations
Duration - Short duration around implantation and activation
Participants receive cochlear implant surgery and activation as part of their clinical care.
1 visit for activation
Duration - Up to 4 years
Participants are followed for up to four years after implantation with routine audiology evaluations, surveys, and yearly in-person speech and language assessments.
Audiology evaluations at approximately 6, 12, 18, 24, 36, and 48 months; yearly in-person speech and language evaluations; parental surveys at baseline and about every 12 months; cognitive surveys at 1 and 2 years after activation
Duration - About 6 months
At select sites, participants and their parents receive Parent-Implemented Communication Treatment consisting of weekly one-hour virtual sessions for about six months to enhance language development.
Weekly virtual sessions for about 6 months; monthly 15-minute parent-child social interaction evaluations during treatment; annual social interaction evaluations for two years after treatment
Trial Site Locations
Total: 1 location
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
N
Nancy M Young, MD
E
Emily (Shimeng) Xu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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