Using brain imaging to improve language outcomes for children with hearing loss
Neural Prediction to Enhance Language Outcomes in Children With Cochlear Implant
This study is testing a new way to use brain scans to help predict and improve language skills in children with hearing loss who are getting cochlear implants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 0 Months to 5 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05962359 on ClinicalTrials.gov |
What this trial studies
This research focuses on developing neural predictive models based on brain imaging to forecast language outcomes for children receiving cochlear implants due to bilateral sensorineural hearing loss. The study aims to create a custom 'predict to prescribe' approach that enhances behavioral therapy for children at risk of poor language development. Up to 700 children will be recruited from five cochlear implant programs across the United States and followed for up to four years post-implantation. Data will be collected from medical records, audiological evaluations, and parental surveys to assess language and communication abilities.
Who should consider this trial
Good fit: Ideal candidates include children aged 5 years and under with bilateral sensorineural hearing loss who are English or Spanish dominant in their home.
Not a fit: Patients with severe motor and/or cognitive disabilities that would prevent proper evaluation of progress may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective interventions that significantly improve language development in children with hearing loss.
How similar studies have performed: Other studies have shown promise in using predictive models for language outcomes in similar populations, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Nancy M Young, MD — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Nancy M Young, MD
- Email: nyoung@luriechildrens.org
- Phone: 312-227-6812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.