Trial of Image-Guided Cochlear Implant Programming Versus Standard of Care (IGCIP vs SOC)

Randomized Controlled Trial of Image-Guided Cochlear Implant Programming Versus Standard of Care

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery, cochlear implants are activated 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 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). In a prospective fashion, the investigators have implemented IGCIP on cochlear implant recipients who have had at least 6 months of standard of care (SOC) mapping. The purpose of this study is to perform a randomized controlled trial (RCT) on newly activated cochlear implant recipients randomizing between IGCIP and SOC.

Study Overview

• Status: Withdrawn
• Conditions: Cochlear Implant
• Intervention / Treatment: Other: Standard of Care; Other: Image-Guided Cochlear Implant Programming

Detailed Description

Over 320,000 individuals have received cochlear implants (CIs) to restore hearing to the hearing impaired. Commercially available CIs have 12, 16, or 22 independent electrodes (the # is dependent on the manufacturer of the CI) which cover the entire frequency spectrum of the cochlea from 20,000 Hertz (Hz) at the base of to 200Hz at the apex. After implantation, an audiologists individually adjusts stimulation levels of each electrode following which all electrodes are turned on such that the whole frequency spectrum of speech can be appreciated. This is known as "standard of care" (SOC) programming. While postoperative speech understanding is significantly better than preoperative levels, even the best performers complain that the fidelity of natural hearing is not reproduced. Additionally, a significant minority achieves poor outcomes despite normally functioning equipment for reasons that are unknown but likely relate to poor neural survival; however, this cannot be confirmed as post-mortem histopathology is required to accurately document spiral ganglion cell count.

In recent years much attention has focused on the interface between the cochlear implant electrodes and the auditory neurons they are stimulating. Technological improvements at Vanderbilt in imaging processing have made it possible to determine the location of each electrode array in relationship to the frequency spectrum of the cochlea.

Using this information, the investigators have developed a new method of CI programming which they call image-guided cochlear implant programming, or IGCIP in which sub-optimally placed electrodes are turned-off or deactivated. Sub-optimally placed electrodes are defined as ones for which their neighboring electrodes are in closer proximity to the site of their neural stimulation. By deactivating sub-optimally positioned electrodes, channel interaction is reduced allowing a cleaner signal to be presented to the auditory nerve.

The investigators have implemented this strategy on 133 CIs of post-lingually deafened (hearing loss after the ability to speak) adult CI users with median use of their CI's with SOC programming of 1.3 years (range 0.3-15.5). When trialing IGCIP, mean word scores increased from 48.8±23.7% to 53.3±22.8% correct, and mean sentence scores increased from 62.2±28.5% to 65.0±26.9% correct. Both of these finding were statistically significant. Extracting out the pre-lingually (hearing loss before the ability to speak) deafened adults, the investigators see that for word scores, 24 of the 133 (28%) had statistically significant improvement 12 of the 133 (9%) had statistically significant decline, and the remaining 97 (73%) had equivocal results. Similarly, for the sentence scores, 36 of the 133 (27%) had statistically significant improvement 24 of the 133 (18%) had statistically significant decline, and the remaining 73 (55%) had equivocal results.

Perhaps the most important metric is which map patients select for long term use - SOC or IGCIP. Ninety-six of the 133 (72.1%) participants elected to keep IGCIP for long term use despite prior research that shows that there is a bias for CI recipients to favor their original map over a new map. And, for the 28% for elected to keep their SOC map, the process involves no risk - the deactivated electrodes are simply reactivated. Given these exciting prospective findings, the investigators are now proposing a randomized controlled trial (RCT) for newly activated adult CI recipients with both the CI user and testing audiologist blinded as to program (SOC or IGCIP). The investigators hypothesize that CI recipients randomized to IGCIP will have improved hearing performance as assessed by both word and sentence testing.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults ≥ 18 years of age that have undergone diagnostic testing for sensorineural hearing loss and are candidates for cochlear implantation will be considered eligible for the study

Exclusion criteria:

• Age < 18 years
• Pre-lingual onset of deafness
• Mini-Mental State Exam < 24 (to remove cognitive decline as a confounding variable)
• Congenital inner ear malformation as detected on pre-operative CT scan performed as routine care
• Non-English speaking (because our audiological speech testing battery is validated for English speakers)
• Have undergone cochlear implantation outside of the Vanderbilt system
• Pregnancy which is a contraindication for elective CT scanning and surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Cochlear Implant programming using standard of care	Other: Standard of Care; Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Standard of Care
Experimental: Image-Guided Cochlear Implant Programming; Cochlear Implant programming using Image-Guided Cochlear Implant Programming	Other: Image-Guided Cochlear Implant Programming; Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Image-Guided Cochlear Implant Programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)	Month 1 post cochlear implant activation
AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)	Month 3 post cochlear implant activation
AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)	Month 6 post cochlear implant activation

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Study Chair: Benoit M. Dawant, PhD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 160461; R01DC014462 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No