Pediatric Image-Guided Cochlear Implant Programming

Completed · Not applicable

Conditions studied: Cochlear Implant

In brief

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Recent literature has indicated that children receiving cochlear implants (CIs) often have dramatically improved speech and language ability relative to previous generations of children with hearing loss; however, many pediatric CI recipients display persistent speech and language disorders despite early implantation and associated speech/language intervention. Cochlear implants are programmed via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care (SOC) mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. Our team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). This project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly improves outcomes in pediatric CI patients.

Key facts

Study ID

NCT03886168

Run by

Vanderbilt University Medical Center

People needed

47

Starts

2019-06-30

Expected to finish

2025-06-30

Last updated by the study team

2026-03-31

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 4 to 12 years of age
• Prelingual onset of deafness
• At least one CI and bilateral moderate to profound sensorineural hearing loss
• for children with a single CI, audiometric thresholds in the non-CI ear must be consistent with at least a moderate to profound sensorineural hearing loss
• Cochlear implantation prior to 4 years of age
• Nonverbal cognitive abilities within the typical range
• No confounding diagnosis such as autism spectrum disorder, neurological disorder, or general cognitive impairment
• Pre-operative CT scan of head performed as standard of care CI work-up
• Post-operative CT scan--obtained either before enrollment (per VUMC CI program standard of care) or after informed consent

You may not qualify if…

• Severe anatomical abnormality(s) of the temporal bone.
• Onset of moderate-to-profound sensorineural hearing loss after 2 years of age
• Nonverbal intelligence standard score < 85

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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