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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT03115203

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Facial Paralysis	Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 8, 2016

Anticipated Primary Completion Date :

Aug 8, 2022

Anticipated Study Completion Date :

Aug 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Facial paralysis	Other: 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 patients with sequelae of facial paralysis
Other: Healthy subject	Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects 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).

Arm

Intervention/Treatment

Other: Facial paralysis

Other: 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 patients with sequelae of facial paralysis

Other: Healthy subject

Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects

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).

Outcome Measures

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. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.))