Tissue Growth Characterization for Cochlear Implant Users

NCT04320251 | Enrolling By Invitation

• 1 other identifier: 192257
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

It is known from post-mortem histological studies that a significant portion of individuals who undergo cochlear implantation (CI) have scar tissue form around the implanted electrode array over time. This scar tissue affects the electrical performance of the cochlear implant, affecting how the implant stimulates the auditory nerve. It is possible that if this scar tissue was detected, the implant programming could be adjusted to account for the changing tissue properties. As part of another study, a computational modeling approach for patient-customized simulation of cochlear implant stimulation is being developed. The simulation approach uses as input CT images and electrophysiological measurements from the cochlear implant device to simulate stimulation by the cochlear implant. These computational simulation models also provide a way to estimate tissue growth around the array. Tissue growth estimates are optimized in the computational model so that electrophysiological metrics simulated by the model match measurements acquired from the patient's implant. In this study, the aim is to collect data necessary to validate these model predictions. While the existence of tissue growth around the implanted array is not typically known for most patients, a subset of cochlear implant recipients need to undergo revision surgery when a device failure or poor placement is suspected. For these individuals, the existence of tissue growth around the array in the base of the cochlea can be visualized in the operating room by the surgeon. Individuals will be recruited who are undergoing CI revision surgery at Vanderbilt University Medical Center to participate in this study. In surgery, the presence of scar tissue growth will be evaluated by visual confirmation by the surgeon.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (1)

• Tissue growth

  Number of individuals with observation of tissue growth around the array by cochlear implant revision surgeon

  intraoperative

Study Arms (1)

1

EXPERIMENTAL

The single observational cohort

Procedure: cochlear implant revision surgery

Interventions

cochlear implant revision surgery PROCEDURE

Observation during routine cochlear implant revision surgery

1

Eligibility Criteria

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

You may qualify if:

• Male or female 18 years of age and above undergoing revision cochlear implant surgery.

You may not qualify if:

• Age \< 18 years or not undergoing revision cochlear implant surgery.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Study Officials

• Jack Noble, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Robert Labadie, MD,PhD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 24, 2020
• Study Start: June 15, 2024
• Primary Completion (Estimated): January 9, 2027
• Study Completion (Estimated): January 9, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)