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Imaging of Facial Neuritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03543384
Recruitment Status : Unknown
Verified February 2018 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
Improved means of positive diagnosis of facial neuritis, the leading cause of peripheral facial palsy

Condition or disease
Facial Neuritis

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Imaging of Facial Neuritis Using T2-weighted Gradient-echo Fast Imaging Employing Steady State Acquisition After Gadolinium Injection
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543384


Contacts
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Contact: Francis VEILLON, MD, PhD 33 3 88 12 78 65 Francis.veillon@chru-strasbourg.fr
Contact: Aïna VENKATASAMY, MD 33 3 88 12 78 65 aina.venkatasamy@chru-strasbourg.fr

Locations
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France
Service Imagerie 1 Recruiting
Strasbourg, France, 67098
Contact: Francis VEILLON, MD, PhD    33 3 88 12 78 65    Francis.veillon@chru-strasbourg.fr   
Contact: Aïna VENKATASAMY, MD, PhD    33 3 88 12 78 65    aina.venkatasamy@chru-strasbourg.fr   
Principal Investigator: Francis VEILLON, MD, PhD         
Sub-Investigator: Aïna VENKATASAMY, MD, PhD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: Francis VEILLON, MD, PhD University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03543384    
Other Study ID Numbers: 6810
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
facial neuritis
T2 weighted gradient-echo
fast imaging employing steady state acquisition (FIESTA-C)
magnetic resonance imaging (MRI)
Additional relevant MeSH terms:
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Facial Nerve Diseases
Neuritis
Facies
Disease Attributes
Pathologic Processes
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases