Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02002572
Other study ID # PI11-DR-DAKPE
Secondary ID 2011-A00532-39
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2011
Est. completion date February 2022

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The SIMOVI project is a collaboration between our Department of Maxillofacial Surgery (CHU Amiens) and the Biomechanical bioengineer Research Department and Roberval Labs (Technological University of Compiègne). The question raised is the extent to which a facial mimic can be evaluated objectively. In today's clinical practice, the investigators use grading systems based on muscular scale or testing, in order to evaluate a facial muscular disorder. This assessment remains subjective because the investigators are deducing from surfacing cutaneous deformations the movement quality of the solicited muscle. This qualitative approach is therefore an approximate approach and deserves to be better thought to plan a surgical treatment which involves mimic facial muscle (as rehabilitation of facial palsy, cleft palate for example), to monitor the results, and to follow the recovery and progress in physiotherapy care. The aim of this study is to correlate external soft tissue movement (essentially cutaneous) during facial mimic with internal movement (essentially facial mimic muscle) using qualitative and QUANTITATIVE indicators, and to perform a biomechanical model of selected mimic face's movement using the precedent data.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2022
Est. primary completion date February 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: - Caucasian subject - Ability to provide informed consent Exclusion Criteria: - Facial pathology - Facial trauma - Pregnant or breastfeeding. - Contraindications to MRI

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Magnetic Resonance Imaging (MRI), Surface scan, Motion capture, Digital Image Correlation


Locations

Country Name City State
France Amiens University Hospital Amiens Picardie

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens Regional Council Picardie, France

Country where clinical trial is conducted

France, 

References & Publications (46)

Autuori B, Bruyere-Garnier K, Morestin F, Brunet M, Verriest JP. Finite element modeling of the head skeleton with a new local quantitative assessment approach. IEEE Trans Biomed Eng. 2006 Jul;53(7):1225-32. doi: 10.1109/TBME.2006.872812. — View Citation

Barbarino GG, Jabareen M, Trzewik J, Nkengne A, Stamatas G, Mazza E. Development and validation of a three-dimensional finite element model of the face. J Biomech Eng. 2009 Apr;131(4):041006. doi: 10.1115/1.3049857. — View Citation

Bensamoun S, Stevens L, Fleury MJ, Bellon G, Goubel F, Ho Ba Tho MC. Macroscopic-microscopic characterization of the passive mechanical properties in rat soleus muscle. J Biomech. 2006;39(3):568-78. doi: 10.1016/j.jbiomech.2004.04.036. — View Citation

Bensamoun SF, Ringleb SI, Littrell L, Chen Q, Brennan M, Ehman RL, An KN. Determination of thigh muscle stiffness using magnetic resonance elastography. J Magn Reson Imaging. 2006 Feb;23(2):242-7. doi: 10.1002/jmri.20487. — View Citation

Brix M, Raphael B. [Labial function]. Ann Chir Plast Esthet. 2002 Oct;47(5):357-69. doi: 10.1016/s0294-1260(02)00129-2. French. — View Citation

Burres S, Fisch U. The comparison of facial grading systems. Arch Otolaryngol Head Neck Surg. 1986 Jul;112(7):755-8. doi: 10.1001/archotol.1986.03780070067015. — View Citation

Burres SA. Facial biomechanics: the standards of normal. Laryngoscope. 1985 Jun;95(6):708-14. doi: 10.1288/00005537-198506000-00013. — View Citation

Burres SA. Objective grading of facial paralysis. Ann Otol Rhinol Laryngol. 1986 May-Jun;95(3 Pt 1):238-41. doi: 10.1177/000348948609500306. — View Citation

Cacou C, Greenfield BE, Hunt NP, McGrouther DA. Patterns of coordinated lower facial muscle function and their importance in facial reanimation. Br J Plast Surg. 1996 Jul;49(5):274-80. doi: 10.1016/s0007-1226(96)90155-1. — View Citation

Chabanas M, Payan Y, Marecaux C, Swider P, Boutault F Comparison of linear and non linear soft tissue models with post-operative CT scan in maxillofacial surgery Lecture notes in computer science 2004, vol 3078, 19-27

Chevallier AM.Rééducation des paralysies faciales centrales et périphériques Encyclopédie Médico-Chirurgicale, Paris Kinésithérapie 26463 B10 5-1990, 16 p

Coulson SE, Croxson GR, Gilleard WL. Three-dimensional quantification of

Croxson G, May M, Mester SJ. Grading facial nerve function: House-Brackmann versus Burres-Fisch methods. Am J Otol. 1990 Jul;11(4):240-6. — View Citation

Deng J, Newton NM, Hall-Craggs MA, Shirley RA, Linney AD, Lees WR, Rodeck CH, McGrouther DA. Novel technique for three-dimensional visualisation and quantification of deformable, moving soft-tissue body parts. Lancet. 2000 Jul 8;356(9224):127-31. doi: 10.1016/S0140-6736(00)02449-1. — View Citation

Duchenne de Boulogne.La mécanique des passions. Paris ,1855

Ekman P, Friesen W.V .Unmasking the face: A guide to recognizing emotions from facial clues Consulting psychologists press (Palo Alto, Californie 1984)

Ermiane.R.Jeux musculaires et expressions du visage.Paris : Le François

Farrugia ME, Bydder GM, Francis JM, Robson MD. Magnetic resonance imaging of facial muscles. Clin Radiol. 2007 Nov;62(11):1078-86. doi: 10.1016/j.crad.2007.05.003. Epub 2007 Aug 9. — View Citation

Farrugia ME, Robson MD, Clover L, Anslow P, Newsom-Davis J, Kennett R, Hilton-Jones D, Matthews PM, Vincent A. MRI and clinical studies of facial and bulbar muscle involvement in MuSK antibody-associated myasthenia gravis. Brain. 2006 Jun;129(Pt 6):1481-92. doi: 10.1093/brain/awl095. Epub 2006 May 3. — View Citation

Gladilin E, Zackav S, Deufhard P, HEGE HC.Towards a realistic simulation of individual facial mimics Stuttgart, Germany, November 21-23, 2001

Hartl DM, Kolb F, Bretagne E, Bidault F, Sigal R. Cine-MRI swallowing evaluation after tongue reconstruction. Eur J Radiol. 2010 Jan;73(1):108-13. doi: 10.1016/j.ejrad.2008.10.005. Epub 2008 Dec 16. — View Citation

Ho Ba Tho MC Bone and joints modelling with individualised geometric and mechanical properties derived from medical images. Computer Mechanics and Engineering Sciences (2003) 4: 3&4. 489-496

Hontanilla B, Auba C. Automatic three-dimensional quantitative analysis for evaluation of facial movement. J Plast Reconstr Aesthet Surg. 2008;61(1):18-30. doi: 10.1016/j.bjps.2007.03.037. Epub 2007 Jun 13. — View Citation

House JW, Brackmann DE. Facial nerve grading system. Otolaryngol Head Neck Surg. 1985 Apr;93(2):146-7. doi: 10.1177/019459988509300202. No abstract available. — View Citation

Isono M, Murata K, Tanaka H, Kawamoto M, Azuma H. An objective evaluation method for facial mimic motion. Otolaryngol Head Neck Surg. 1996 Jan;114(1):27-31. doi: 10.1016/S0194-59989670279-6. — View Citation

Kleinheinz J, Joos U. Imaging of cartilage and mimic muscles with MRI: anatomic study in healthy volunteers and patients with unilateral cleft lip and palate. Cleft Palate Craniofac J. 2001 Jul;38(4):291-8. doi: 10.1597/1545-1569_2001_038_0291_iocamm_2.0.co_2. — View Citation

Lacide.M, Chevallier .AM Evaluation clinique de la fonction musculaire.

Le Double AF.Traité des variations du système musculaire de l'homme1897, Paris : Schleicher frères

Linstrom CJ, Silverman CA, Susman WM. Facial-motion analysis with a video and computer system: a preliminary report. Am J Otol. 2000 Jan;21(1):123-9. doi: 10.1016/s0196-0709(00)80086-1. — View Citation

Luboz V, Chabanas M, Swider P, Payan Y. Orbital and maxillofacial computer aided surgery: patient-specific finite element models to predict surgical outcomes. Comput Methods Biomech Biomed Engin. 2005 Aug;8(4):259-65. doi: 10.1080/10255840500289921. — View Citation

Meier-Gallati V, Scriba H, Fisch U. Objective scaling of facial nerve function based on area analysis (OSCAR). Otolaryngol Head Neck Surg. 1998 Apr;118(4):545-50. doi: 10.1177/019459989811800419. — View Citation

Paletz JL, Manktelow RT, Chaban R. The shape of a normal smile: implications for facial paralysis reconstruction. Plast Reconstr Surg. 1994 Apr;93(4):784-9; discussion 790-1. — View Citation

Payan Y, Chabanas M, Pelorson X, Vilain C, Levy P, Luboz V, Perrier P. Biomechanical models to simulate consequences of maxillofacial surgery. C R Biol. 2002 Apr;325(4):407-17. doi: 10.1016/s1631-0691(02)01443-9. English, French. — View Citation

Pessa JE, Zadoo VP, Adrian EK Jr, Yuan CH, Aydelotte J, Garza JR. Variability of the midfacial muscles: analysis of 50 hemifacial cadaver dissections. Plast Reconstr Surg. 1998 Nov;102(6):1888-93. doi: 10.1097/00006534-199811000-00013. — View Citation

Poirrier P, Charpy A.Traité d'anatomie humaine..Myologie, vol. 2, 1901, Paris, Masson

Rouvière H .Anatomie humaine descriptive, topographique et fonctionnelle.Tome 1, Tête et cou, 15e édition

Rubin LR. The anatomy of a smile: its importance in the treatment of facial paralysis. Plast Reconstr Surg. 1974 Apr;53(4):384-7. doi: 10.1097/00006534-197404000-00002. No abstract available. — View Citation

Sangeux M, Marin F, Charleux F, Durselen L, Ho Ba Tho MC. Quantification of the 3D relative movement of external marker sets vs. bones based on magnetic resonance imaging. Clin Biomech (Bristol, Avon). 2006 Nov;21(9):984-91. doi: 10.1016/j.clinbiomech.2006.05.006. Epub 2006 Jul 17. — View Citation

Sobotta.Atlas d'anatomie humaine - Tome 13 - Edition française.Edition Médicale Internationale, 1994

Testud L.Traité d'anatomie humaine.1899, Paris

Tomat LR, Manktelow RT. Evaluation of a new measurement tool for facial paralysis reconstruction. Plast Reconstr Surg. 2005 Mar;115(3):696-704. doi: 10.1097/01.prs.0000152431.55774.7e. — View Citation

Tran H V (2007) Determination of the mechanical properties of the skin in vivo. PhD Dissertation, Université de Technologie de Compiègne

Tran HV, Charleux F, Rachik M, Ehrlacher A, Ho Ba Tho MC. In vivo characterization of the mechanical properties of human skin derived from MRI and indentation techniques. Comput Methods Biomech Biomed Engin. 2007 Dec;10(6):401-7. doi: 10.1080/10255840701550287. Epub 2007 Sep 24. — View Citation

Wang S, Yang J, Gee JC. Advances in collision detection and non-linear finite mixed element modelling for improved soft tissue simulation in craniomaxillofacial surgical planning. Int J Med Robot. 2010 Mar;6(1):28-41. doi: 10.1002/rcs.286. — View Citation

Wang S, Yang J. Simulating cranio-maxillofacial surgery based on mixed-element biomechanical modelling. Comput Methods Biomech Biomed Engin. 2010 Jun;13(3):419-29. doi: 10.1080/10255840903317386. — View Citation

Wood DA, Hughes GB, Secic M, Good TL. Objective measurement of normal facial movement with video microscaling. Am J Otol. 1994 Jan;15(1):61-5. — View Citation

* Note: There are 46 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Morphometric assessment of mimic facial muscle from 3T MRI data The aim is to valid a method to identify, describe and measure the mimic facial muscles in 3 Tesla MRI. Through particular MRI acquisition developed especially for mimic facial muscle from routine acquisition, Morphometrics properties are calculated as length, volume, thickness and cross physiological section area. 30 min
Secondary Three dimensional quantitative analysis of mimics through motion capture A VICON motion capture system with the Nexus 1.7.1 software will be used to capture expressive facial movements at a 120 Hz sample rate with 7 T160 cameras and 2 MX30 cameras. Markers of a diameter of 1.5 mm will be placed on the face. The localization of the markers is related to the muscles involved in the movements we want to study.
After data capture, we build and reconstruct our model. We chose a neutral pose as reference. The best parameters for the reconstruction will be determined. Kinematic parameters will be the markers displacement.
01 hour
Secondary Three dimensional quantitative mimic facial analysis with surface scan. Three-dimensional image captured with a MH WHALE 3D Scanner. 01 hour
Secondary Three dimensional analysis with Digital Image Correlation Recording three-dimensional images of the deformations of the face by two pairs of Pike CCD cameras from Allied Vision Technologies, with Schneider Xenoplan 2.0/28mm Lens, positioned on both sides of the face.
The calibration and the image processing will be made with the software suite VIC-SNAP, VIC-3D and 3D Fusion (Correlated Solutions)
01 hour