Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological and Control Subjects (AQ2MF)
Primary Purpose
Electromyography, Eye-tracking, Facial Palsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dental impressions
Simultaneous MoCap and EMG acquisition
Eye-tracking acquisition for pathological subjects
Follow-up visit for pathological subjects
Sponsored by
About this trial
This is an interventional other trial for Electromyography focused on measuring facial mimics, motion capture, electromyography, eye-tracking, Facial Palsy
Eligibility Criteria
Inclusion Criteria:
- Subjects with no known facial pathology (healthy volunteers) OR
- Patients with peripheral facial palsy, irrespective of grade, whether or not previously treated
- Subject with written informed consent
- Subject over 18 years of age
- Subject affiliated to a social security scheme
Exclusion Criteria:
- Subjects with severe skin disorders that do not allow the application of electrodes or photo reflective markers
- Subjects with speech disorders making it impossible to pronounce the sounds [o] and [pu]
- Subject unable to provide written informed consent
- Subjects under guardianship, curators or safeguard of justice
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patients with facial palsy
healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
determination of the maximum range of motion of facial mimicry (in millimetres) in patients
determination of the maximum range of motion facial mimicry (in millimetres) in patients
determination of the maximum range of motion of eye-tracking (in millimetres) in patients
determination of the maximum range of motion of eye-tracking (in millimetres) in patients
Secondary Outcome Measures
Full Information
NCT ID
NCT05581680
First Posted
October 12, 2022
Last Updated
October 25, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05581680
Brief Title
Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological and Control Subjects
Acronym
AQ2MF
Official Title
Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The facial palsy is a frequent disease with a lot of etiologies. It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed treatments are based on surgery, physiotherapy and botulinum toxin injections. However, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. Thanks to Motion Capture and Electromyography, a quantification of the facial mimicry is now possible with a great precision. In addition with the quantification of the facial mimicry, eye-tracking, wich is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular, will be used to evaluate the visio of the patients on their pathology in function of the movement quantification measured with MoCap and Electromyography. The aim of this research is to measure in a combined way the action potentials by sEMG and the amplitudes of displacement of the markers in motion capture, for movements determined in a population of patients presenting a facial pathology, in order to compare them with reference values obtained in healthy subjects. In a second step, the aim will be to study if there is a link between the way the patient looks at his pathology and the results of his management (treatment, rehabilitation) which will be quantitatively evaluated thanks to MoCap and sEMG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electromyography, Eye-tracking, Facial Palsy
Keywords
facial mimics, motion capture, electromyography, eye-tracking, Facial Palsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with facial palsy
Arm Type
Experimental
Arm Title
healthy volunteers
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
dental impressions
Intervention Description
dental impressions
Intervention Type
Other
Intervention Name(s)
Simultaneous MoCap and EMG acquisition
Intervention Description
Simultaneous MoCap and EMG acquisition
Intervention Type
Other
Intervention Name(s)
Eye-tracking acquisition for pathological subjects
Intervention Description
Eye-tracking acquisition for pathological subjects
Intervention Type
Other
Intervention Name(s)
Follow-up visit for pathological subjects
Intervention Description
Follow-up visit for pathological subjects
Primary Outcome Measure Information:
Title
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
Description
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
Time Frame
one month
Title
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
Description
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
Time Frame
one month
Title
determination of the maximum range of motion of facial mimicry (in millimetres) in patients
Description
determination of the maximum range of motion facial mimicry (in millimetres) in patients
Time Frame
one year
Title
determination of the maximum range of motion of eye-tracking (in millimetres) in patients
Description
determination of the maximum range of motion of eye-tracking (in millimetres) in patients
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with no known facial pathology (healthy volunteers) OR
Patients with peripheral facial palsy, irrespective of grade, whether or not previously treated
Subject with written informed consent
Subject over 18 years of age
Subject affiliated to a social security scheme
Exclusion Criteria:
Subjects with severe skin disorders that do not allow the application of electrodes or photo reflective markers
Subjects with speech disorders making it impossible to pronounce the sounds [o] and [pu]
Subject unable to provide written informed consent
Subjects under guardianship, curators or safeguard of justice
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Dakpé, Pr
Phone
03 22 08 90 50
Email
dakpe.stephanie@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie DAKPE, Dr
Phone
+33322668322
Email
dakpe.stephanie@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
François-Régis Sarhan, DR
First Name & Middle Initial & Last Name & Degree
Emilien Colin, Dr
First Name & Middle Initial & Last Name & Degree
Félix Marcellin, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological and Control Subjects
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