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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve hearing outcomes for children with cochlear implants through a new programming method called Image-Guided Cochlear Implant Programming (IGCIP). The method customizes implant settings based on detailed ear images, potentially enhancing speech and language development. The trial includes two groups: one receives the new programming immediately, while the other experiences a delay. Children aged 4 to 12 with early-onset hearing loss and at least one cochlear implant may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future cochlear implant programming.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this image-guided cochlear implant programming method is safe for children?

Research shows that cochlear implants, which assist individuals with hearing loss, are generally safe. The FDA has approved these devices for treating hearing loss. A new programming method, Image-Guided Cochlear Implant Programming (IGCIP), uses images of the implant to tailor adjustments for each person.

Regarding safety, studies have found that remotely programming cochlear implants, similar to IGCIP, is safe and effective. No major safety issues have been reported for these types of adjustments. This suggests that IGCIP should also be safe for patients, although specific safety data for IGCIP isn't detailed in the sources. Overall, the technology has a strong safety record in similar applications, making it a promising option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the image-guided programming for cochlear implants because it introduces a personalized approach to signal processing. Unlike standard cochlear implant programming, which often relies on generic settings, this method uses imaging to tailor the signal processing specifically to the individual's ear anatomy. This has the potential to enhance hearing outcomes by optimizing how sound is processed for each person. The trial explores both immediate and deferred interventions, allowing researchers to assess the benefits and timing of this tailored approach.

What evidence suggests that image-guided cochlear implant programming is effective for improving speech and language outcomes in children?

Research shows that Image-Guided Cochlear Implant Programming (IGCIP) can greatly improve hearing for people with cochlear implants. Studies have found that IGCIP leads to better hearing results, especially in adults. This trial will compare two approaches: Immediate IGCIP, where the signal processing intervention is applied right away, and Deferred IGCIP, where the intervention is delayed. Researchers use CT scans to create a detailed map of the implant, allowing for a more personalized way to stimulate the ear. Early evidence suggests that IGCIP might also boost speech and language skills in children by focusing on the connection between the implant and the ear's nerve pathways. This method could be more effective than traditional approaches that don't consider the exact position of the implant in the ear. ^{6 7 8 9 10}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4849538/

Initial results with image-guided cochlear implant ... IGCIP has been shown to lead to significant improvement in hearing outcomes for adults with CIs (14). IGCIP could be even more significant for pediatric implant ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/68/NCT03886168/Prot_003.pdf

Protocol Title Based on our published and preliminary data (4,20), our hypotheses are that IGCIP will improve 1) auditory function (spectral and/or temporal resolution), 2) ...

3. nidcd.nih.gov nidcd.nih.gov/sites/default/files/2022-05/sanitized-giffordcamarataapplicationsummary-dc017683-01a1.pdf

Summary Statement for Application Number 1 R01 DC017683 ... We will use predictor analyses to determine the impact of immediate and deferred IGCIP on subsequent auditory, speech, language, and literacy outcomes. PUBLIC ...

4. karger.com karger.com/aud/article/19/6/400/51828/Clinical-Evaluation-of-an-Image-Guided-Cochlear

Clinical Evaluation of an Image-Guided Cochlear Implant ... In this article, we present results of an image-guided, patient-customized approach to stimulation that utilizes the electrode position information.

5. researchgate.net researchgate.net/publication/362747591_Image-Guided_Cochlear_Implant_Programming_A_Systematic_Review_and_Meta-analysis

Image-Guided Cochlear Implant Programming Previous studies have shown that IGCIP can significantly improve hearing outcomes for adults with CIs. Methods: The IGCIP technique was ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED) It is recommended that prior to cochlear implantation, individuals with SSD have at least two. (2) weeks to one (1) month experience wearing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4305276/

Clinical evaluation of an image-guided cochlear implant ... In this article, we present results of experiments testing how this image-guided, patient-customized approach to stimulation, which we have termed Image-Guided ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03886168

Pediatric Image-Guided Cochlear Implant Programming This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200021B.pdf

Summary of Safety and Effectiveness Data (SSED) Effect of different signal-processing options on speech-in-noise recognition for cochlear implant recipients with the cochlear CP810 speech processor. J Am ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6380526/

Remote Programming of Cochlear Implants - PMC The results from this multicenter study demonstrate that remote programming of cochlear implants via telecommunication is safe, yields similar ...