Revision Surgery for Cochlear Implant Tissue Growth

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Age < 18, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment cochlear implant revision surgery?

Research shows that revision cochlear implant surgery can lead to improved speech perception and good outcomes, especially when addressing issues like device failure or electrode misplacement.¹ ² ³ ⁴ ⁵

Is revision surgery for cochlear implants generally safe?

Revision surgery for cochlear implants is generally considered safe, but like any surgery, it can have complications. Studies show that while failures and complications can occur, they are relatively rare, and revision surgeries are performed to address these issues.¹ ³ ⁶ ⁷ ⁸

How is revision surgery for cochlear implant tissue growth different from other treatments?

Revision surgery for cochlear implant tissue growth is unique because it involves reoperation to address complications like device migration or electrode extrusion, which are not typically addressed by other treatments. This surgery may involve repositioning or replacing parts of the implant to restore function, and it is often necessary due to the high cost and complexity of cochlear implants.² ⁴ ⁶ ⁷ ⁹

Research Team

Jack Noble, PhD

Principal Investigator

Vanderbilt University

Robert Labadie, MD,PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults over the age of 18 who are already using cochlear implants and need to have revision surgery. It's not open to anyone under 18 or those who aren't scheduled for this type of surgery.

Inclusion Criteria

I am 18 or older and need another cochlear implant surgery.

Exclusion Criteria

I am under 18 years old or I am not having repeat cochlear implant surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Observation

Participants undergo cochlear implant revision surgery where the presence of scar tissue growth is evaluated by visual confirmation by the surgeon

Intraoperative

Data Collection and Analysis

Data necessary to validate computational model predictions of tissue growth is collected and analyzed

4-8 weeks

Follow-up

Participants are monitored for any post-surgical complications and the effectiveness of the computational model predictions

4 weeks

Treatment Details

Interventions

cochlear implant revision surgery

Trial Overview The study tests a new way to use CT images and device measurements to simulate how cochlear implants work in the ear, especially when scar tissue forms around them. The goal is to see if these simulations can help improve implant programming by predicting tissue growth.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

The single observational cohort