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RecruitingNCT03115203SIMOVI IRM 2Updated May 13, 2026

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

An interventional study of Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis and Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects in Facial Paralysis, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Facial Paralysis

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Keywords

  • muscle skin
  • IRM 3 tesla
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.))
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • Other
    Healthy subject

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

Interventions

  • OtherCarry 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

  • OtherCarry 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).

05

What researchers measure

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.

    Time frame: 5 years

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03115203
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Apr 14, 2017
Start date
Aug 8, 2016
Primary completion
Aug 8, 2027 (estimated)
Completion
Aug 8, 2027 (estimated)
Last update
May 13, 2026

Study contacts

Stéphanie DAKPE, Dr
Contact
dakpe.stephanie@chu-amiens.fr
+33322668322

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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