Role of Diagnostic Imaging in Cochlear Implant

Cochlear Implant Clinical Trial

Official title:

Role of Diagnostic Imaging in Evaluation of Cochlear Implant Candidate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711538
• Other study ID #: Soh-Med-21-01-05
• Status: Recruiting
• Start date: February 2021
• Est. completion date: October 2022

Study information

• Verified date: January 2021
• Source: Sohag University
• Contact: Marwa H Elhadad, AI
• Phone: 01122029281
• Email: marwa.elhadad[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

Device:
• MRI
imaging inner ear and petrous bone of the candidate by MRI and CT

Locations

Country	Name	City	State
Egypt	Sohag University	Sohag	Sohag Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Alam-Eldeen MH, Rashad UM, Ali AHA. Radiological requirements for surgical planning in cochlear implant candidates. Indian J Radiol Imaging. 2017 Jul-Sep;27(3):274-281. doi: 10.4103/ijri.IJRI_55_17. — View Citation

Joshi VM, Navlekar SK, Kishore GR, Reddy KJ, Kumar EC. CT and MR imaging of the inner ear and brain in children with congenital sensorineural hearing loss. Radiographics. 2012 May-Jun;32(3):683-98. doi: 10.1148/rg.323115073. — View Citation

Marsot-Dupuch K, Meyer B. Cochlear implant assessment: imaging issues. Eur J Radiol. 2001 Nov;40(2):119-32. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identification inner ear congenital and acquired abnormalities	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