- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03543384
Imaging of Facial Neuritis
May 31, 2018 updated by: University Hospital, Strasbourg, France
Imaging of Facial Neuritis Using T2-weighted Gradient-echo Fast Imaging Employing Steady State Acquisition After Gadolinium Injection
Improved means of positive diagnosis of facial neuritis, the leading cause of peripheral facial palsy
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67098
- Recruiting
- Service Imagerie 1
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Contact:
- Aïna VENKATASAMY, MD, PhD
- Phone Number: 33 3 88 12 78 65
- Email: aina.venkatasamy@chru-strasbourg.fr
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Sub-Investigator:
- Aïna VENKATASAMY, MD, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with neuritis facial (neuritis group) who benefited, between 2009 and 2016, from an MRI of the internal auditory ducts, with gadolinous product injection and on the MRI 3 Tesla
Description
Inclusion Criteria:
- Age 18-80 years
- Subject giving their consent for their participation
- Patients with neuritis facial (neuritis group) who benefited, between 2009 and 2016, from an MRI of the internal auditory ducts, with gadolinous product injection and on the MRI 3 Tesla
- Patients with a perception deafness, without neuritis sign (control group) who also benefited from an MRI with gadolinous product injection on the MRI 3T with the same protocol.
Exclusion Criteria:
- Refusal to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence or absence of pathologic enhancement of the facial nerve on the symptomatological side of the T2 sequence (FIESTA-C)
Time Frame: 1 hour after the realization of the MRI
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1 hour after the realization of the MRI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2018
Primary Completion (Anticipated)
February 1, 2019
Study Completion (Anticipated)
February 1, 2019
Study Registration Dates
First Submitted
February 26, 2018
First Submitted That Met QC Criteria
May 31, 2018
First Posted (Actual)
June 1, 2018
Study Record Updates
Last Update Posted (Actual)
June 1, 2018
Last Update Submitted That Met QC Criteria
May 31, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6810
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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