Clinical Trial

Neural Prediction to Enhance Language

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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-07-21; most recent amendment 2026-06-30.
Trial Details
NCT Number NCT05962359
Lead Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: Chinese University of Hong Kong, Northwestern University, University of North Carolina, Chapel Hill, University of Southern California, University of Miami, The University of Texas at Dallas
Conditions Bilateral Sensorineural Hearing Loss, Speech and Language Development Delay Due to Hearing Loss, Social Communication
Enrollment 700 participants
Start Date 2023-01-23
Primary Completion 2027-07-23 (estimated)
Study Completion 2028-01-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-02