NCT03115203 Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.
| NCT ID | NCT03115203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Facial Paralysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2016-08-08 |
| Primary Completion | 2027-08-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2016-08-08 with a primary completion date of 2027-08-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.))
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03115203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Facial Paralysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03115203 currently recruiting?
Yes, NCT03115203 is actively recruiting participants. Contact the research team at dakpe.stephanie@chu-amiens.fr for enrollment information.
Where is the NCT03115203 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT03115203 clinical trial?
NCT03115203 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 60 participants.