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Hearing Loss, SensorineuralNCT04131439

CT and MRI for Pre-Operative Cochlear Imaging

An observational study of Hearing Loss, Sensorineural, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hearing Loss, Sensorineural
What is being tested?
Computed Tomography and Magnetic resonance imaging
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Dec 2019to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mohamed S Sadek, Mc.S contact

01003915007

Mohamedsalahsadek77@gmail.com

Egypt1 site, 1 recruiting
  • Assiut university

    Asyut, 71515

    Mohamed Salah, MSc, +201003975007

    Recruiting

Other trials in Egypt

About this study

Official title: Role of Multislice Computed Tomography and Magnetic Resonance Imaging in Preoperative Cochlear Implant Evaluation

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.

Read the detailed description

Cochlear implant is the treatment of choice for deep sensorineural hearing loss, notably in those patients for whom conventional amplification devices do not provide significant clinical improvement. Imaging plays an important role in the workup of cochlear implant candidates not only to identify inner ear congenital and acquired abnormalities or cochlear nerve anomalies but also to detect temporal bone abnormalities that may be encountered during surgery and may alter surgical approach.

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.

The radiologist and surgeon must be familiar with these imaging findings. Both computed tomography and magnetic resonance imaging should be used as they delineate, in different manners, cochlear and middle ear anatomy as well as other anatomical variants.

Mastoid pneumatization is important for planning the surgery. It is classified into pneumatic, diploic, sclerotic, and mixed. Effusion of the middle ear cleft should also be reported.

Korner's septum divides the mastoid process into a superficial squamous portion and a deep petrous portion. It may mislead the surgeon to the mastoid antrum during surgery. Mastoid emissary veins participate in extracranial venous drainage of the posterior fossa dural sinuses. Most of them disappear, however, some persist and enlarge.

Low lying dura represents difficulty to access the aditus, lateral semicircular canal, and posterior tympanotomy. It is often associated with sclerotic mastoid. Posterior tympanotomy is a well known otologic procedure that allows surgeons to access the middle ear cavity. The surgeon opens a window in the posterior wall of the middle ear in the angle between the chorda tympani and the mastoid part of the facial nerve. Laterally or anteriorly positioned mastoid part of the facial nerve may hinder the access to the facial recess or may even force the surgeon to change his approach.

The sigmoid sinus passes along the posteromedial border of the mastoid air cells. An anteriorly located sinus produces a deep bulge in the mastoid and may reach the posterior wall of the external auditory canal being separated from it only by a thin bony plate.

Jugular bulb variations are common, the roof of a normal jugular bulb lies either at or slightly below the level of the external auditory canal floor and is separated from the middle ear cavity by the thin bony sigmoid plate. The average width of the jugular bulb is 1 cm. A jugular bulb larger than 1 cm is called a giant or mega jugular bulb. A jugular bulb that extends over the basal turn of the cochlea or abuts the round window is called a high riding jugular bulb. Dehiscence of the sigmoid plate with upward protrusion of the bulb into the posterior hypotympanum is called a dehiscent jugular bulb, which may obliterate a round window niche.

The aberrant internal carotid artery is an enlarged inferior tympanic artery that occurs as a result of agenesis or underdevelopment of the cervical segment of the internal carotid artery. It runs along the medial aspect of the middle ear coursing anteriorly across the cochlear promontory to join the horizontal carotid canal through a dehiscence in the carotid plate.

Cochlear duct patency and axis, patency of the round window niche and the patent even caliber of the cochlea must be adequately evaluated by both computed tomography and magnetic resonance imaging. Otospongiotic foci compromise the insertion of the cochlear implant electrode if they occlude the round window niche or cochlear duct. Labyrinthitis ossificans may partially or completely obliterate cochlear lumen. Fibrosis may precede ossification and areas of fibrosis and ossification may coexist. Cochlear ossification with luminal obstruction is not a contraindication for implantation, however, it is important to be identified preoperatively.

Vestibular aqueduct (VA) is considered dilated if its width is greater than the width of the posterior SCC or if its midpoint width is greater than 1.5 mm. Computed tomography shows dilatation of the VA only whereas magnetic resonance imaging shows the dilatation of the VA and of the endolymphatic sac.

Being tested
Computed Tomography and Magnetic resonance imaging
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed Tomography and Magnetic resonance imagingDiagnostic test

    Preoperative imaging for patients undergoing cochlear implants

Study groups in NCT04131439
Study groupRoleWhat they receive
"cochlear implantation" group"cochlear implantation" group: patients undergoing cochlear implantation between December 2019 and December 2021in the ENT department of Assiut university hospital.
Receives: Diagnostic Test: Computed Tomography and Magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2019
  2. Study start1 Dec 2019
  3. Primary completionNov 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04131439
Sponsor's protocol ID
Imaging in Cochlear implant
Status last verified
Jul 2022
First submitted
16 Oct 2019
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27891421
  • 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.

    PubMed 17414036
  • 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.

    PubMed 11584231
  • 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.

    PubMed 26693449

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss, Sensorineural, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed S Sadek, Mc.S (01003915007, Mohamedsalahsadek77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identifying contraindications for cochlear implant (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04131439, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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