CT and MRI for Pre-Operative Cochlear Imaging

NCT04131439 | Unknown

• 1 other identifier: Imaging in Cochlear implant
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the role of the preoperative computed tomography (CT) and magnetic resonance imaging (MRI) before cochlear implants and their role in selecting suitable patients for surgery.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Identifying contraindications for cochlear implant

  Identifying contraindications for cochlear implant including * cochlear nerve aplasia (evidenced by MRI) * cochlear and/or labyrinthine aplasia * absence of the internal auditory canal and of the petrous apex bone * absence or fusion of the ossicles

  Day 0

Study Arms (1)

"cochlear implantation" group

"cochlear implantation" group: patients undergoing cochlear implantation between December 2019 and December 2021in the ENT department of Assiut university hospital.

Diagnostic Test: Computed Tomography and Magnetic resonance imaging

Interventions

Computed Tomography and Magnetic resonance imaging DIAGNOSTIC_TEST

Preoperative imaging for patients undergoing cochlear implants

"cochlear implantation" group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be performed in Assiut University Hospital, Department of Radiology during the period from May 2019 to May 2021, and will include 50 patients from different age groups and both sex who will be clinically diagnosed as having severe to profound SNHL and fulfill the criteria for the cochlear implant.

You may qualify if:

• Patients fulfilled criteria for cochlear implant including audiological criteria (as bilateral profound hearing loss not benefiting from hearing aid) and phoniatric criteria as IQ (using Stanford Binet intelligence scale) more than 80 with no medical, surgical, or radiological contraindication for surgery
• Family motivation and commitment for audiologic and phoniatric rehabilitation and follow up
• Confirmation of the presence of cochlear nerve using preimplant MRI.

You may not qualify if:

• Patient who did not fulfill the criteria for indicating cochlear implant surgery
• Patients with no records of preoperative investigations
• Patients with major dysplasia or aplasia of the cochlea as a common cavity.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

RECRUITING

Related Publications (4)

• Digge P, Solanki RN, Shah DC, Vishwakarma R, Kumar S. Imaging Modality of Choice for Pre-Operative Cochlear Imaging: HRCT vs. MRI Temporal Bone. J Clin Diagn Res. 2016 Oct;10(10):TC01-TC04. doi: 10.7860/JCDR/2016/18033.8592. Epub 2016 Oct 1.

  PMID: 27891421 BACKGROUND

• Trimble K, Blaser S, James AL, Papsin BC. Computed tomography and/or magnetic resonance imaging before pediatric cochlear implantation? Developing an investigative strategy. Otol Neurotol. 2007 Apr;28(3):317-24. doi: 10.1097/01.mao.0000253285.40995.91.

  PMID: 17414036 BACKGROUND

• Westerhof JP, Rademaker J, Weber BP, Becker H. Congenital malformations of the inner ear and the vestibulocochlear nerve in children with sensorineural hearing loss: evaluation with CT and MRI. J Comput Assist Tomogr. 2001 Sep-Oct;25(5):719-26. doi: 10.1097/00004728-200109000-00009.

  PMID: 11584231 BACKGROUND

• Jallu AS, Jehangir M, Ul Hamid W, Pampori RA. Imaging Evaluation of Pediatric Sensorineural Hearing Loss in Potential Candidates for Cochlear Implantation. Indian J Otolaryngol Head Neck Surg. 2015 Dec;67(4):341-6. doi: 10.1007/s12070-015-0819-6. Epub 2015 Jan 7.

  PMID: 26693449 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Tomography, X-Ray Computed; Magnetic Resonance Imaging

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Abdelkarim H Abdallah, Professor

  Assiut University

  STUDY CHAIR

• Hazem A Yousef, MD

  Assiut University

  STUDY DIRECTOR

• Reham A Mahmoud, MD

  Assiut University

  STUDY DIRECTOR

• Mohamed A Mohamed, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Mohamed Salah sadek Ibrahim, Master

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mohamed S Sadek, Mc.S

CONTACT

01003915007; Mohamedsalahsadek77@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: December 1, 2019
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)