Tissue Growth Characterization for Cochlear Implant Users

Not Applicable

• Conditions: Cochlear Implant
• Interventions: Procedure: cochlear implant revision surgery

• Registration Number: NCT04320251
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-21
• Study First Posted: 2020-03-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-15
• Study Start: 2025-06-15
• Primary Completion: 2026-01-09
• Study Completion: 2026-01-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	cochlear implant revision surgery	The single observational cohort

Primary Outcome Measures

Name	Time	Method
Tissue growth	intraoperative	Number of individuals with observation of tissue growth around the array by cochlear implant revision surgeon

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States