Image-Guided Programming for Cochlear Implants

Recruiting in Palo Alto (17 mi)

Overseen byStephen Camarata, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rene Gifford, PhD

Principal Investigator

Vanderbilt University Medical Center

Stephen Camarata, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for children aged 4-12 with cochlear implants, implanted before age 4 due to prelingual deafness. They must have moderate to profound sensorineural hearing loss in both ears (or the non-CI ear), no severe cognitive impairments or disorders like autism, and typical nonverbal cognitive abilities. Severe temporal bone abnormalities or postlingual onset of hearing loss are disqualifiers.

Inclusion Criteria

I have been deaf since birth or before I learned to speak.

No confounding diagnosis such as autism spectrum disorder, neurological disorder, or general cognitive impairment

I have severe hearing loss in both ears.

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Exclusion Criteria

I have a severe structural issue with my ear bone.

Nonverbal intelligence standard score < 85

I started losing my hearing significantly after I turned 2 years old.

Treatment Details

Interventions

Signal processing intervention of a biomedical device (Signal Processing Intervention)

Trial OverviewThe study tests a new method called Image-guided Cochlear Implant Programming (IGCIP) that uses CT scans to map the relationship between implant electrodes and neural interface for better customization. It aims to see if this personalized mapping improves speech and language outcomes in kids with cochlear implants.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate IGCIPExperimental Treatment1 Intervention

Immediate signal processing intervention of a biomedical device

Group II: Deferred IGCIPActive Control1 Intervention

Delayed signal processing intervention of a biomedical device