TIMAGINGEvaluation of Electrode-modiolus Distance and Cochlear Fibrosis Using Depth Sounding and Spectroscopy Tools: Comparison With Postoperative Cone Beam CT
Data Collection
Ear Diseases+9
+ Fibrosis
+ Hearing Disorders
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 12, 2023
Actual date on which the first participant was enrolled.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)
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.180 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University Hospital Montpellier
Montpellier, FranceOpen University Hospital Montpellier in Google Maps