Facial Nerve ParalysisNCT03469427
Multislice Computed Tomography in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma
An observational study of Facial Nerve Paralysis, run by Assiut University at 1 site in Egypt.
Trial summary
Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures. The onset of paralysis may be immediate, delayed or undetermined, the latter of which often occurs in unconscious patients with accompanying life-threatening complications.About one fourth has complete paralysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Facial Nerve Paralysis
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 1 Feb 2020
- 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: Patients of different age groups presented with facial nerve paralysis due to temporal bone trauma
Who may be able to join
- All patients with temporal bone fracture presented with facial nerve paralysis of immediate onset and meet the criteria of facial nerve exploration regardless of age and sex.
Who cannot join
- Pregnant women.
- Unfit patients for surgery.
- Patients refuse surgical intervention.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut
Sally Hanna, Bachelor, Romleletot15@gmail.com
About this study
Official title: Reliability of Multislice Computed Tomography Scan in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma
Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures.
The onset of paralysis may be immediate, delayed or undetermined, the latter of which often occurs in unconscious patients with accompanying life-threatening complications.About one fourth has complete paralysis.
Read the detailed description
Facial nerve paralysis might have variable etiologies apart from idiopathic Bell's palsy, Congenital, infectious, inflammatory, neoplastic, neurological, toxic, iatrogenic and atraumatic causes.
Surgical intervention is indicated if 90-95% loss of function is seen at the very early period on Electroneuronography or if there is axonal degeneration on Electromyography lately with no sign of recovery.
High-resolution multislice computed tomography of the temporal bone is routinely required for evaluation of traumatic facial paralysis. High-resolution multislice computed tomography is known to be the best method for evaluating the intratemporal course of the facial nerve, but it has some limitations as well. Occasionally, the surgeon may encounter facial nerve injuries which have not been revealed in the preoperative computed tomography.
There are limited data in recent medical publications evaluating the diagnostic value of temporal bone High-resolution multislice computed tomography in the evaluation of traumatic facial paralysis. Therefore, in this study,the investigators will compare the findings of preoperative high-resolution multislice computed tomography with surgical findings to determine the diagnostic value of computed tomography.
- Conditions
- Facial Nerve Paralysis
- Medical subject headings
- Bell Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography
Evaluation the reliability of multislice computed tomography in the assessment of facial nerve paralysis due to temporal bone trauma
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 May 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Nerve ParalysisStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally S Hanna, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469427
- Sponsor's protocol ID
- RCTFPTBT
- Status last verified
- Jul 2018
- First submitted
- 12 Mar 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Multislice Computed Tomography Scan in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma
- ClinicalTrials.gov ID
- NCT03469427
- Acronym / sponsor ID
- RCTFPTBT
- Conditions
- Facial Nerve Paralysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 19 Mar 2018 (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.
Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures.
The onset of paralysis may be immediate, delayed or undetermined, the latter of which often occurs in unconscious patients with accompanying life-threatening complications.About one fourth has complete paralysis.
Detailed description
Facial nerve paralysis might have variable etiologies apart from idiopathic Bell's palsy, Congenital, infectious, inflammatory, neoplastic, neurological, toxic, iatrogenic and atraumatic causes.
Surgical intervention is indicated if 90-95% loss of function is seen at the very early period on Electroneuronography or if there is axonal degeneration on Electromyography lately with no sign of recovery.
High-resolution multislice computed tomography of the temporal bone is routinely required for evaluation of traumatic facial paralysis. High-resolution multislice computed tomography is known to be the best method for evaluating the intratemporal course of the facial nerve, but it has some limitations as well. Occasionally, the surgeon may encounter facial nerve injuries which have not been revealed in the preoperative computed tomography.
There are limited data in recent medical publications evaluating the diagnostic value of temporal bone High-resolution multislice computed tomography in the evaluation of traumatic facial paralysis. Therefore, in this study,the investigators will compare the findings of preoperative high-resolution multislice computed tomography with surgical findings to determine the diagnostic value of computed tomography.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of different age groups presented with facial nerve paralysis due to temporal bone trauma
Key inclusion criteria (1 listed)
- All patients with temporal bone fracture presented with facial nerve paralysis of immediate onset and meet the criteria of facial nerve exploration regardless of age and sex.
Key exclusion criteria (3 listed)
- Pregnant women.
- Unfit patients for surgery.
- Patients refuse surgical intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography
Time frame: up to 2 years
Evaluation the reliability of multislice computed tomography in the assessment of facial nerve paralysis due to temporal bone trauma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Facial Nerve Paralysis, 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 1 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 6 Jul 2018. 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 Mahmoud Mohamed Ragheb, Professor (00201003317723, Mmraghib@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who suffer from facial nerve paralysis due to temporal bone trauma will be diagnosed by using multislice computed tomography (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2018.