Image-Guided Programming for Cochlear Implants

Overseen By Linsey Sunderhaus, AuD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Autism, Neurological disorder, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 6 months

47 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Rene Gifford, PhD

Principal Investigator

Vanderbilt University Medical Center

Stephen Camarata, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of auditory function, speech recognition, PA, reading, speech, and language abilities for pediatric CI users

4 weeks

1 visit (in-person)

Treatment

Immediate or deferred Image-guided Cochlear Implant Programming (IGCIP) intervention

6 months

3 visits (in-person) at 2, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Periodic visits (in-person) over 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Signal processing intervention of a biomedical device

Trial Overview The 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.

How Is the Trial Designed?

Group I: Immediate IGCIP Experimental Treatment 1 Intervention

Immediate signal processing intervention of a biomedical device

Group II: Deferred IGCIP Active Control 1 Intervention

Delayed signal processing intervention of a biomedical device

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+