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.
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.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71515
Mohamed Salah, MSc, +201003975007
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.
- Conditions
- Hearing Loss, Sensorineural
- 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 group | Role | What 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.
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.
- First posted18 Oct 2019
- Study start1 Dec 2019
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdel-Tawab Mohamed, Assiut University
- Investigators
- Abdelkarim H Abdallah, Professor, Study chair, Assiut UniversityHazem A Yousef, MD, Study director, Assiut UniversityReham A Mahmoud, MD, Study director, Assiut UniversityMohamed A Mohamed, MD, Principal investigator, Assiut UniversityMohamed Salah sadek Ibrahim, Master, Study director, Assiut University
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 27891421Trimble 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 17414036Westerhof 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 11584231Jallu 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Multislice Computed Tomography and Magnetic Resonance Imaging in Preoperative Cochlear Implant Evaluation
- ClinicalTrials.gov ID
- NCT04131439
- Acronym / sponsor ID
- Imaging in Cochlear implant
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "cochlear implantation" group | – | Diagnostic Test: Computed Tomography and Magnetic resonance imaging"cochlear implantation" group: patients undergoing cochlear implantation between December 2019 and December 2021in the ENT department of Assiut university hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed Tomography and Magnetic resonance imagingPreoperative imaging for patients undergoing cochlear implants | Diagnostic test | "cochlear implantation" group |
Primary outcome
Identifying contraindications for cochlear implant
Time frame: Day 0
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 27891421Digge 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.
- Background: PubMed 17414036Trimble 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.
- Background: PubMed 11584231Westerhof 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.
- Background: PubMed 26693449Jallu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelkarim H Abdallah, Professor study chair
Assiut University
Hazem A Yousef, MD study director
Assiut University
Reham A Mahmoud, MD study director
Assiut University
1 site in 1 country: see every site and its status.
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.