Image-guided Cochlear Implant Programming (IGCIP)

NCT03306082 | Enrolling By Invitation

• 2 other identifiers: 150417R01DC014037
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. The research 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). The study collects data in a prospective fashion for those CI recipient undergoing IGCIP.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (1)

• AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)

  Month 1 post cochlear implant activation

Secondary Outcomes (1)

• Minimum Speech Test Battery

  Month 1 post cochlear implant activation

Study Arms (1)

Image-guided Cochlear Implant Programming (IGCIP)

EXPERIMENTAL

Cochlear implant programming using IGCIP.

Other: Image-Guided Cochlear Implant Programming

Interventions

Image-Guided Cochlear Implant Programming OTHER

Post Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant.

Image-guided Cochlear Implant Programming (IGCIP)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 90 years that have undergone diagnostic testing for sensorineural hearing loss and have received a cochlear implant with asymptotic improvement in performance with SOC programming will be considered eligible for the study.

You may not qualify if:

• Age \< 18 years or \> 90 years
• Non-English speaking (because our audiological speech testing battery is validated for English speakers)
• Pregnancy which is a contraindication for elective CT scanning and surgery

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Jack H. Noble, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Rene H. Gifford, PhD

  Vanderbilt University Medical Center

  STUDY CHAIR

• Robert F. Labadie, MD, PhD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor, Electrical Engineering and Computer Science

Model Details: Prospective Cohort study

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 10, 2017
• Study Start: June 23, 2015
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)