Role of Diagnostic Imaging in Cochlear Implant

January 13, 2021 updated by: Marwa Helmy Abdel Hamid Elhadad, Sohag University

Role of Diagnostic Imaging in Evaluation of Cochlear Implant Candidate

cochlear implant is a well accepted treatment to profound sensorineural hearing loss. Imaging provides essential information about anatomical Variants that could be riskyand should be considered by cochlear implant surgeon and the aim of the study:-

  • Identify inner ear congenital and acquired abnormalities.
  • Identify cochlear nerve anomalies.
  • Detect temporal bone abnormalities that require surgical modification by cochlear implant surgeon.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cochlear implant (CI) is a well-accepted treatment for severe to profound sensorineural hearing loss. Patients who are refractory to conventional hearing augmentation .

(CI) is a surgically implanted device consisting of external and internal components. An external microphone and speech processor worn behind the ear and convert sound into an electrical signal. A magnet held external transmitter sends the signal via electromagnetic induction through the skin to an internal receiver- stimulator which converts the signal into rapid electrical impulses which distributed to multiple electrodes on an electrode array implanted within the cochlea. The electrodes electrically stimulate the spiral ganglion cells along the cochlear turns, which then travel along the auditory nerve axons to the brain for sound perception .

Imaging provides essential information about many of the anatomical variations that could be risky and should be considered by cochlear implant surgeon to avoid complications.

Some variations are potential surgical hazards that may lead to problems during the surgery and may alert the surgeon regarding potential surgical dangers and complications .

Both computed tomography (CT) and magnetic resonance imaging(MRI) are complementary to each other. They detect cochlear, middle ear anatomy and the anatomical variants .

The strength of CT is visualization of the bony structures of the middle and inner ear and the strength of MRI is visualization of the fluid content of the membranous labyrinth, visualization of the vestibule-cochlear nerve in the fluid filled internal auditory canal and the cerebello-pontine angle .

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt, 82524
        • Recruiting
        • Sohag University
        • Contact:
        • Contact:
          • Ramadan H Sayed, Prof
          • Phone Number: 01000632007
        • Principal Investigator:
          • Marwa H Elhadad, AL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who suffering from deep to profound sensorineural hearing loss( inculde any age,both genders)

Description

Inclusion Criteria:

  • Age, any age will included
  • Gender, both genders will be included.
  • Patient full filled criteria for CI including audiological & phoniatric criteria

Exclusion Criteria:

  • • Patient who did not fulfill the criteria for indicating CI surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
identification inner ear congenital and acquired abnormalities
Time Frame: immediately after end of imaging and diagnosis
detect role of MRI and CT in identification of cochlear nerve anomlies,detect temporal bone abnormalities that require surgical modification by cochlear implant surgeon.
immediately after end of imaging and diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Mohammed H Alam-Eldeen, AP, Sohag university Hospital
  • Study Chair: Ramadan H Hashem, Prof, Sohag university Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med-21-01-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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