Quantification, Analysis and Simulation of Facial Mimics Movements (SIMOVI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Collaborator:
Regional Council Picardie, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT02002572
First received: December 2, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Mimic Facial Muscles
Other: Magnetic Resonance Imaging (MRI), Surface scan, Motion capture, Digital Image Correlation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Morphometric assessment of mimic facial muscle from 3T MRI data [ Time Frame: 30 min ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Three dimensional quantitative analysis of mimics through motion capture [ Time Frame: 01 hour ] [ Designated as safety issue: No ]

    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.


  • Three dimensional quantitative mimic facial analysis with surface scan. [ Time Frame: 01 hour ] [ Designated as safety issue: No ]
    Three-dimensional image captured with a MH WHALE 3D Scanner.

  • Three dimensional analysis with Digital Image Correlation [ Time Frame: 01 hour ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mimic facial muscle from 3T MRI data Other: Magnetic Resonance Imaging (MRI), Surface scan, Motion capture, Digital Image Correlation

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian subject
  • Ability to provide informed consent

Exclusion Criteria:

  • Facial pathology
  • Facial trauma
  • Pregnant or breastfeeding.
  • Contraindications to MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002572

Contacts
Contact: Bernard DEVAUCHELLE, MD, phD 033 3 22 66 83 25 devauchelle.bernard@chu-amiens.fr
Contact: Stéphanie DAKPE, MD 033 3 22 66 83 25 dakpe.stephanie@chu-amiens.fr

Locations
France
Amiens University Hospital Recruiting
Amiens, Picardie, France, 80054
Contact: Stéphanie DAKPE, MD    0033 3 22 66 83 25    dakpe.stephanie@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Regional Council Picardie, France
Investigators
Study Director: Bernard DEVAUCHELLE, MD, phD Department of Maxillofacial Surgery, Amiens University Hospital
Principal Investigator: Stéphanie DAKPE, MD Department of Maxillofacial Surgery, Amiens University Hospital
  More Information

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

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02002572     History of Changes
Other Study ID Numbers: CHU AMIENS - PI11 - Dr DAKPE, 2011-A00532-39
Study First Received: December 2, 2013
Last Updated: December 5, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Facial Mimic Muscle
MRI
Segmentation
Three dimensional assessment
Motion capture
Movement analysis
Digital Image Correlation

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014