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Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis. (SIMOVI IRM 2)

Primary Purpose

Facial Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Facial Paralysis focused on measuring muscle skin, IRM 3 tesla

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject, for which a diagnosis of facial paralysis has been made, female or male, over 18 years of age.

Exclusion Criteria:

  • Pregnancy and lactation,
  • a patient with a contra-indication to MRI (Claustrophobia, Pace Maker, Neurosurgical Clips, Vascular Clips, Cardiac Valves, V.peritoneal Valves, Cochlear Implant, Neuro-Stimulator, Intra-Orbital Metal Shards (Articular Prosthesis, Dental Prosthesis, Contact Glass, Insulin Pumps, Intrauterine Device, Tattoo, Piercing / Implants.))

Sites / Locations

  • CHU Amiens PicardieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Facial paralysis

Healthy subject

Arm Description

Outcomes

Primary Outcome Measures

The measurement of the volume of the large zygomatic muscle in patients with facial paralysis compared to the mean volume of the large zygomatic muscle in healthy subjects.

Secondary Outcome Measures

Full Information

First Posted
March 31, 2017
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03115203
Brief Title
Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.
Acronym
SIMOVI IRM 2
Official Title
Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2016 (Actual)
Primary Completion Date
August 8, 2023 (Anticipated)
Study Completion Date
August 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The problem posed is the possibility of objectively assessing facial muscle mobility. Today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the House Brackman [1] or EMG scale of the facial nerve but does not distinguish each muscle individually . Objective measurements of skin muscles such as thickness and volume, in preoperative assessment of a facial paralysis rehabilitation surgery, would be useful in order to choose the most appropriate surgical technique. Indeed, too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap. Similarly, it would be useful to be able to objectively evaluate the recovery of muscle function after facial allo-transplantation. Although electromyography has been developed since the work of Duchenne de Boulogne, little research has been carried out on the development of noninvasive methods to objectively characterize in vivo skin muscles (variation, position, orientation, morphometry). The main morphometric data of the skin muscles come from anatomical dissections. Imaging of the skin muscles has not been specifically developed. Some studies have been carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia gravis, facial paralysis, and labio-alveolo-palatine clefts for example. The originality of the project is to develop a method allowing to establish a quantitative correlation between the movements of the face and the muscular changes. This correlation will be achieved by associating muscular morphological data derived from MRI acquisitions and cutaneous deformations resulting from clinical examinations. This non-invasive approach should make it possible to establish objective and reproducible indicators in patients with facial paralysis sequelae.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paralysis
Keywords
muscle skin, IRM 3 tesla

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Facial paralysis
Arm Type
Other
Arm Title
Healthy subject
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis
Intervention Description
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis
Intervention Type
Other
Intervention Name(s)
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects
Intervention Description
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle in healthy subjects (data obtained from the SIMOVI project being published).
Primary Outcome Measure Information:
Title
The measurement of the volume of the large zygomatic muscle in patients with facial paralysis compared to the mean volume of the large zygomatic muscle in healthy subjects.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject, for which a diagnosis of facial paralysis has been made, female or male, over 18 years of age. Exclusion Criteria: Pregnancy and lactation, a patient with a contra-indication to MRI (Claustrophobia, Pace Maker, Neurosurgical Clips, Vascular Clips, Cardiac Valves, V.peritoneal Valves, Cochlear Implant, Neuro-Stimulator, Intra-Orbital Metal Shards (Articular Prosthesis, Dental Prosthesis, Contact Glass, Insulin Pumps, Intrauterine Device, Tattoo, Piercing / Implants.))
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie DAKPE, Dr
Phone
+33322668322
Email
dakpe.stephanie@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie DAKPE, Dr
Phone
+33322668322
Email
dakpe.stephanie@chu-amiens.fr

12. IPD Sharing Statement

Learn more about this trial

Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.

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