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Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools

NCT05402969 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2024-05-29

No results posted yet for this study

Summary

Cochlear fibrosis development can compromise the success and the outcomes of the cochlear implantation (CI) thus affecting the quality of life of the implanted patient. Correlating the results of the Transimpedance Matrix (TIM) measurements to the implant electrode location determined by the Cone Beam Computer Tomography (CBCT), this study aims to identify a range of TIM profiles within the implanted population, certain profiles suggesting the growth of the fibrosis tissue in cochlea

Conditions

Interventions

PROCEDURE

Transimedance Matrix measurements

TIM measurements are based on cochlear implant back-telemetry function. Each electrode contact is stimulated in monopolar mode. Transimpedance is represented by the ratio between the voltage measured at each recording electrode and the current injected at the stimulation contact. The result of the measurements is a matrix of 21x21 transimpedances. Stimulation current cannot be perceived by a patient thus making TIM measurements a non-invasive and painless procedure. The test duration is only 2-3 minutes

PROCEDURE

Depth sounding and spectroscopy

Depth sounding and spectroscopy are based on the matrixes obtained after TIM imaging. Deep sounding measures the capacitances throughout the electrode array whereas spectroscopy determines the phase of every transimpedance value. These tests take 10 to 15 minutes together. The stimulation intensity used by depth sounding technique can be perceived by a patient. If it is considered as unpleasant, the test will be stopped.

PROCEDURE

Cone Beam Computer Tomography

CBCT is a routine postoperative assessment after CI, non-invasive and painless for patients.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2024-07-12
Completion
2025-01-12

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05402969 on ClinicalTrials.gov