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

NCT02815124 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-01-20

No results posted yet for this study

Summary

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.

Conditions

  • Cochlear Implant

Interventions

OTHER

Standard of Care

Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Standard of Care

OTHER

Image-Guided Cochlear Implant Programming

Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Image-Guided Cochlear Implant Programming

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Robert F. Labadie, MD, PhD · Vanderbilt University Medical Center

  • Benoit M. Dawant, PhD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02815124 on ClinicalTrials.gov