Image-Guided Programming for Cochlear Implants

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Non-English speaking, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the programming of cochlear implants, which help individuals with hearing loss regain their hearing. The new method, Image-Guided Cochlear Implant Programming, uses CT scans to more accurately map the implant's electrodes to the inner ear, aiming for personalized and effective hearing restoration. Individuals with cochlear implants who aren't experiencing optimal improvement might be suitable candidates. This trial targets those who have received implants but find their progress with standard programming insufficient. As an unphased trial, it offers participants a unique opportunity to potentially enhance their hearing experience through innovative programming techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that this method is safe for cochlear implant programming?

Research has shown that cochlear implants, like those studied in image-guided cochlear implant programming (IGCIP), are generally safe. With over 320,000 recipients, there is extensive experience with these devices. Studies indicate that using images to guide programming can enhance hearing and quality of life, particularly for children.

No specific safety concerns have been reported with the image-guided method itself. This approach adjusts the implant's settings based on detailed ear images, increasing effectiveness. While all surgeries carry some risks, cochlear implant surgeries are common and typically proceed smoothly. To date, there are no reports of increased problems with the image-guided approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Image-Guided Cochlear Implant Programming (IGCIP) because it enhances the precision of cochlear implant adjustments. Unlike traditional cochlear implant programming, which relies on subjective feedback from the patient, IGCIP uses advanced imaging to tailor the implant's settings more accurately. This method could lead to improved hearing outcomes by optimizing the implant's performance for each individual's unique ear anatomy. By potentially reducing trial-and-error in programming, IGCIP might offer faster, more reliable results for those with hearing loss.

What evidence suggests that Image-guided Cochlear Implant Programming is effective for cochlear implant recipients?

Research has shown that Image-Guided Cochlear Implant Programming (IGCIP), which participants in this trial will receive, can greatly improve hearing. Studies have found that this method enhances speech understanding in both quiet and noisy environments. IGCIP uses post-surgery scans to adjust the implant's electrodes, tailoring the hearing experience to each individual. This approach has demonstrated promise in boosting both patient satisfaction and quality of life. Overall, evidence suggests that IGCIP could make a meaningful difference for cochlear implant users. ^{2 3 6 7 8}

Who Is on the Research Team?

Rene H. Gifford, PhD

Principal Investigator

Vanderbilt University Medical Center

Robert F. Labadie, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Jack H. Noble, PhD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 90 with sensorineural hearing loss who have received a cochlear implant and seen limited improvement. Candidates must speak English due to the test battery used. Pregnant individuals or those outside the age range are excluded.

Inclusion Criteria

I am between 18 and 90 years old, have sensorineural hearing loss, and received a cochlear implant.

Exclusion Criteria

I am not pregnant, as it would prevent me from having certain medical scans and surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative CT Scanning

Participants undergo post-operative CT scanning to determine the relationship between cochlear implant electrodes and the neural interface

1 week

1 visit (in-person)

Image-guided Cochlear Implant Programming (IGCIP) Trial

Participants undergo a 1-month trial of IGCIP where sub-optimally placed electrodes are deactivated

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for audiological outcomes and can choose between IGCIP or SOC for long-term programming

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cochlear Implant Surgery
• Image-Guided Cochlear Implant Programming

Trial Overview The study tests 'Image-guided Cochlear Implant Programming' (IGCIP), which uses post-op CT scans to map out where cochlear implant electrodes sit in relation to the neural interface, potentially improving hearing by deactivating poorly positioned electrodes.

How Is the Trial Designed?

Group I: Image-guided Cochlear Implant Programming (IGCIP) Experimental Treatment 1 Intervention

Cochlear implant programming using IGCIP.

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+

Published Research Related to This Trial

The proposed image-guided cochlear implant programming (IGCIP) system uses CT images to identify and reduce cross-electrode neural stimulation overlap, leading to significantly improved hearing outcomes for patients with cochlear implants.

An automated technique for selecting electrode configurations has been developed, which performs as well as previous methods but is more generic and requires fewer parameters, enhancing the efficiency of the programming process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selecting electrode configurations for image-guided cochlear implant programming using template matching. Zhang, D., Zhao, Y., Noble, JH., et al.[2020]

Citations

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

Clinical evaluation of an image-guided cochlear implant ... This individualized mapping strategy yields significant improvement in speech understanding in both quiet and noise as well as improved spectral resolution in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03306082

Image-guided Cochlear Implant Programming (IGCIP) The study collects data in a prospective fashion for those CI recipient undergoing IGCIP. Detailed Description. Over 320,000 individuals have received cochlear ...

3. apps.asha.org apps.asha.org/EvidenceMaps/Articles/ArticleSummary/656f2aa6-086a-ee11-8147-005056834e2b

A Systematic Review and Meta-analysis Image-guided cochlear implant programming (IGCIP) demonstrates promise in subjective patient preference and quality of life outcomes.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35973035/

Image-Guided Cochlear Implant Programming Objective: To review studies evaluating clinically implemented image-guided cochlear implant programing (IGCIP) and to determine its effect on ...

5. withpower.com withpower.com/trial/phase-5-2015-ae126?lat=36.65114&lng=-97.3517

Image-Guided Programming for Cochlear Implants Research shows that using image-guided programming for cochlear implants can improve hearing outcomes in both children and adults. This method helps customize ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26756157/

Initial Results With Image-guided Cochlear Implant ... Our results indicate that image guidance significantly improves hearing and QOL outcomes for pediatric CI recipients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03886168

Pediatric Image-Guided Cochlear Implant Programming This project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP) significantly improves outcomes in pediatric ...

8. 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.