Role of Diagnostic Imaging in Cochlear Implant

NCT ID: NCT04711538

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-10-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Cochlear Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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MRI

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

Intervention Type DEVICE

Other Intervention Names

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CT imaging

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Helmy Abdel Hamid Elhadad

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohammed H Alam-Eldeen, AP

Role: STUDY_DIRECTOR

Sohag University

Ramadan H Hashem, Prof

Role: STUDY_CHAIR

Sohag University

Locations

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Sohag University

Sohag, Sohag Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa H Elhadad, AI

Role: CONTACT

01122029281

Mohammed T Mahmoud, Prof

Role: CONTACT

01064469957

Facility Contacts

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Mohamad T Mahmoud, Prof

Role: primary

01064469957

Ramadan H Sayed, Prof

Role: backup

01000632007

References

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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.

Reference Type BACKGROUND
PMID: 29089672 (View on PubMed)

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.

Reference Type RESULT
PMID: 22582354 (View on PubMed)

Marsot-Dupuch K, Meyer B. Cochlear implant assessment: imaging issues. Eur J Radiol. 2001 Nov;40(2):119-32. doi: 10.1016/s0720-048x(01)00380-1.

Reference Type RESULT
PMID: 11704359 (View on PubMed)

Other Identifiers

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Soh-Med-21-01-05

Identifier Type: -

Identifier Source: org_study_id

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