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

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Brief Title

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

Official Title

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

Brief 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
    

Detailed 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)
    


Study Type

Observational


Primary Outcome

TIM profiles in patients with long-term implantation

Secondary Outcome

 TIM profiles depending on electrode array and inner ear access

Condition

Sensorineural Hearing Loss

Intervention

Transimedance Matrix measurements

Study Arms / Comparison Groups

 Patients with long-term implantation
Description:  Patients undergone CI more than 6 months ago. After the study is presented to the patient and the egligibility criterias are verified, the patient is proposed to sign a consent form (visit 0). Once the consent form is signed, the visit 1 is scheduled (0 to 90 days after the visit 0). During the visit 1 TIM measurements are performed, including depth sounding and spectroscopy, and adversed affects if any are collected.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

180

Start Date

June 2022

Completion Date

June 2024

Primary Completion Date

December 2023

Eligibility 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
      

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

, +33467336890, [email protected]



Administrative Informations


NCT ID

NCT05402969

Organization ID

RECHMPL20_0666


Responsible Party

Sponsor

Study Sponsor

University Hospital, Montpellier


Study Sponsor

, , 


Verification Date

May 2022