3 Tesla MRI measurements of facial skin muscles in people with facial paralysis
Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.
This will use a 3 Tesla MRI to see if measuring facial muscle thickness and volume helps understand muscle loss and guide care for adults with facial paralysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT03115203 on ClinicalTrials.gov |
What this trial studies
Participants with chronic facial paralysis and healthy volunteers will undergo high-resolution 3 Tesla MRI to obtain morphometric measurements (thickness, volume) of superficial facial muscles, with special attention to the zygomaticus major. Images will be analyzed to quantify muscle atrophy and compare affected sides to the contralateral side and to controls. The goal is to produce objective muscle metrics that could inform surgical planning (for example, choosing between hypoglossal-facial anastomosis, temporalis elongation myoplasty, or free muscle transfer) and track recovery after reconstructive procedures. Adults with MRI contraindications, pregnancy, or lactation are excluded.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of facial paralysis who can safely undergo 3 Tesla MRI and are not pregnant or breastfeeding are the ideal candidates.
Not a fit: People who cannot have MRI (for example due to pacemakers, certain implants, claustrophobia), pregnant women, and children under 18 are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could provide objective measurements to help surgeons choose the most appropriate reconstruction method and to monitor muscle recovery over time.
How similar studies have performed: While electromyography and some MRI work exist for facial function, detailed morphometric 3T MRI of individual facial muscles is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.))
Where this trial is running
Amiens, Picardie
- CHU Amiens Picardie — Amiens, Picardie, France (Recruiting)
Study contacts
- Study coordinator: Stéphanie DAKPE, Dr
- Email: dakpe.stephanie@chu-amiens.fr
- Phone: +33322668322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.