Tissue Growth Characterization for Cochlear Implant Users

Cochlear Implant Clinical Trial

Official title:

Tissue Growth Characterization for Cochlear Implant Users

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04320251
• Other study ID #: 192257
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: January 9, 2025

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: January 9, 2025
• Est. primary completion date: January 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

Procedure:
• cochlear implant revision surgery
Observation during routine cochlear implant revision surgery

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue growth	Number of individuals with observation of tissue growth around the array by cochlear implant revision surgeon	intraoperative