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

NCT05402969 | Recruiting

• 1 other identifier: RECHMPL20_0666
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

Sensorineural Hearing Loss; Fibrosis

Keywords

Cochlear implantation; Cochlear fibrosis; Transimpedance matrix measurement; Cochlear implant

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (3)

• TIM profiles depending on electrode array and inner ear access

  Visit 1 (0 to 90 days after inclusion)

• Depth sounding versus the distance electrode - spiral ganglion

  Visit 1 (0 to 90 days after inclusion)

• Spectroscopy of the specific electrode insertion zones

  Visit 1 (0 to 90 days after inclusion)

Study Arms (2)

Patients with long-term implantation

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.

Procedure: Transimedance Matrix measurements; Procedure: Depth sounding and spectroscopy; Procedure: Cone Beam Computer Tomography

Recently implanted patients

Patients enrolled at their pre-op appointments (visit 0 - egligibilty criterias are verified and the consent collected). Visit 1 (0 to 90 days after visit 0) is a surgery. TIM measurements, icluding deep sound and spectroscopy, are performed after the CI and all adverse events are noted. CBCT is routinely done the next day after CI. TIM measurements (as well as adverse event collection) are repeated during visits 2, 3, 4, 5 and 6 (appoitments 15 days, 1, 2, 3 and 6 months after the surgery).

Procedure: Transimedance Matrix measurements; Procedure: Depth sounding and spectroscopy; Procedure: Cone Beam Computer Tomography

Interventions

Transimedance Matrix measurements PROCEDURE

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

Also known as: TIM measurements

Patients with long-term implantation; Recently implanted patients

Depth sounding and spectroscopy PROCEDURE

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.

Patients with long-term implantation; Recently implanted patients

Cone Beam Computer Tomography PROCEDURE

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

Also known as: CBCT

Patients with long-term implantation; Recently implanted patients

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

160 patients undergone CI more than 6 months ago will be enrolled during their routine checks-up at the University Hospital, Montpellier. This group will include 80 individuals with perimodiolar electrode (Contour Advanced or Slim Modiolar) and 80 individuals with lateral electrode (Slim Straight Array). 20 patients scheduled for CI will be enrolled during their pre-op appointment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Fibrosis

Interventions

Spectrum Analysis

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Venail Frederic, MD, PhD

CONTACT

+33467336890; f-venail@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: January 12, 2023
• Primary Completion: July 12, 2024
• Study Completion: January 12, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

FR (1)