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

Fibrosis Clinical Trial

— TIMAGING  

Official title:

Evaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402969
• Other study ID #: RECHMPL20_0666
• Status: Recruiting
• Start date: January 12, 2023
• Est. completion date: January 12, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Venail Frederic, MD, PhD
• Phone: +33467336890
• Email: f-venail[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Fibrosis tissue growth after the CI is an inflammatory reaction to a foreign body occurring around the electrode array. It is considered responsible for a larger current diffusion, less precise stimulation of auditory nerve fibres and elevated electrical impedances thus affecting the functioning and the battery life of an implant. Fibrosis has been also proposed as a factor reducing residual hearing. Hence, its early detection and prevention can significantly improve the outcomes of CI. To date, no reliable technique to visualise cochlear fibrosis in vivo exists. However, the TIM measurement developed by Cochlear® including depth sounding and spectroscopy tools could possibly provide a better "view" of the fibrosis apparition after CI. This approach has been already successfully applied in the University Hospital of Montpellier, France, to the patients-users of the Advanced Bionics cochlear implants. One of the factors provoking the fibrosis tissue development is an electrode positioning into the scala vestibule (SV) versus scala tympani (ST). CBCT will be used to visualise the electrode location as well as possible damages of the inner ear caused by CI. The imaging data will be then linked to the TIM measurements results. Potential participants will be recruited from the French population of the Cochlear® implant users either coming for their regular checks-up at the ENT service of the University Hospital of Montpellier and implanted for more than 6 month (time necessary for the fibrosis tissue to develop) or recently implanted at the same hospital. For the patients with long-term implantation (160 participants planned) the TIM measurements will be performed only once whereas the newly implanted group (20 participants planned) will require these measurements to be repeated several times: on the day of the surgery as well as 15 days, 1 month, 2 months, 3 months and 6 months after it. For the first group the post operational CBCT imaging file will be extracted from the patient medical record; for the second group CBCT will be performed during the surgery. The main objective of this study is: For the group with long-term implantation - to show the difference in TIM profiles according to the electrode scala position (ST or SV) determined by CBCT 6 months or more after the implantation For the group with recent implantation - to evaluate the changes in TIM profiles with time according to the electrode scala position (ST or SV) determined by CBCT The secondary objectives are common for both groups: - To analyse various patient subgroups defined by the electrode type (Contour Advanced - only for long-term implantation, Slim Straight, Slim Modiolar) and the inner ear access (round window, enlarged round window or cochleostomy) - To identify the TIM profile threshold values, potential indicators of the cochlear fibrosis apparition, depending on the electrode type - To evaluate the depth sounding tool accuracy for the measurement of the distance between the electrode and the spiral ganglion in comparison to CBCT depending on the type of the electrode array. - To evaluate the spectroscopy tool accuracy for fibrosis detection in specific cochlear areas (around electrodes dislocated to SV or basal electrodes in case of cohleostomy)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 12, 2025
• Est. primary completion date: July 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

Group with long-term implantation:

• Age18 years or older
• Affiliation to the French social security
• Signed and dated informed consent form
• Users of uni or bilateral cochlear implants for more than 6 months (CI24CA, CI422, CI512, CI522, CI532, CI612; CI622; CI632), in primo-implantation or reimplantation, with more than 18 electrodes active
• Postoperation CBCT imaging results available

Recently-implanted group:

• Age18 years or older
• Affiliation to the French social security
• Signed and dated informed consent form
• Indication for CI622 or CI632 cochlear implants
• Postoperation CBCT imaging results available

Exclusion Criteria:

• Vulnerable individuals (minors, adults protected in accordance to the French Public Health code, patients deprived of liberty by court decision)
• Daily usage of the cochlear implant for less than 4 hours or weekly usage for less than 5 days
• Failure or disfunction of the cochlear implant

Related Conditions & MeSH terms

• Fibrosis
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

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
• 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.
• Cone Beam Computer Tomography
CBCT is a routine postoperative assessment after CI, non-invasive and painless for patients.

Locations

Country	Name	City	State
France	University Hospital Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIM profiles in patients with long-term implantation	Comparison of TIM profiles of patients with ST electrode position versus patients with SV electrode dislocateon in the long-term implantation group	Visit 1 (0 to 90 days after inclusion)
Primary	TIM profiles time dynamics in the recently implanted patients	Assessment of the TIM profile changes with time and depending on electrode scala position in newly-implanted patients	Visit 1 - surgery (0 to 90 days after inclusion), visit 3, 4, 5, 6 (1, 2, 3 and 6 months after surgery)
Secondary	TIM profiles depending on electrode array and inner ear access	Comparison of the TIM profiles depending on the electrode array type and inner ear access	Visit 1 (0 to 90 days after inclusion)
Secondary	Depth sounding versus the distance electrode - spiral ganglion	Correlation of the depth sounding measures with the electrode-spiral ganglion distance assesed through CBCT imaging	Visit 1 (0 to 90 days after inclusion)
Secondary	Spectroscopy of the specific electrode insertion zones	Comparison of the spectroscopy measures in the specific zones prone to electrode insertion damages (180° turn and basal part) between groups with ST electrode positioning and SV electrode dislocation	Visit 1 (0 to 90 days after inclusion)