Actively Recruiting

Phase Not Applicable
Age: 0Months - 5Years
All Genders
NCT05962359

Neural Prediction to Enhance Language

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2024-08-05

700

Participants Needed

1

Research Sites

260 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

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.

CONDITIONS

Official Title

Neural Prediction to Enhance Language

Who Can Participate

Age: 0Months - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 years or younger with sensorineural hearing loss meeting clinical criteria for bilateral cochlear implantation
  • English or Spanish as the dominant language spoken at home
  • For treatment arm: English dominant spoken language by family
  • For treatment arm: Age at implantation 36 months or younger when treatment begins
  • For treatment arm: Parent or caregiver willing to participate and understands spoken English
  • For treatment arm: Child exposed to spoken language by at least one parent in the home
Not Eligible

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 as the dominant family language at home (for model building arm)
  • Dominant language other than English (for treatment arm)
  • Diagnoses or medical conditions expected to affect language development independent of hearing loss
  • Cochlear nerve deficiency in implanted ears or severe cochlear malformation
  • Children with spoken language scoring better than 25th percentile on CDI Words and Sentences evaluation
  • Child with more than two months of cochlear implant experience prior to treatment start

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

N

Nancy M Young, MD

CONTACT

E

Emily (Shimeng) Xu, PhD

CONTACT

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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