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

NCT03115203 | Unknown

• 1 other identifier: PI2016_843_0013
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Paralysis

Keywords

muscle skin; IRM 3 tesla

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Facial paralysis

OTHER

Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis

Healthy subject

OTHER

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

Interventions

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 patients with sequelae of facial paralysis

Facial paralysis

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

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).

Healthy subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.))

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stéphanie DAKPE, Dr

CONTACT

+33322668322; dakpe.stephanie@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 14, 2017
• Study Start: August 8, 2016
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)