- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05581680
Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological and Control Subjects (AQ2MF)
May 22, 2025 updated by: Centre Hospitalier Universitaire, Amiens
Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
720
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stéphanie Dakpé, Pr
- Phone Number: 03 22 08 90 50
- Email: dakpe.stephanie@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- Recruiting
- CHU Amiens Picardie
-
Sub-Investigator:
- François-Régis Sarhan, DR
-
Sub-Investigator:
- Emilien COLIN, Dr
-
Sub-Investigator:
- Félix Marcellin, Dr
-
Contact:
- Stéphanie DAKPE, Dr
- Phone Number: +33322668322
- Email: dakpe.stephanie@chu-amiens.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients with facial palsy
|
dental impressions
Simultaneous MoCap and EMG acquisition
Eye-tracking acquisition for pathological subjects
Follow-up visit for pathological subjects
|
|
Active Comparator: healthy volunteers
|
dental impressions
Simultaneous MoCap and EMG acquisition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
Time Frame: one month
|
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
|
one month
|
|
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
Time Frame: one month
|
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
|
one month
|
|
determination of the maximum range of motion of facial mimicry (in millimetres) in patients
Time Frame: one year
|
determination of the maximum range of motion facial mimicry (in millimetres) in patients
|
one year
|
|
determination of the maximum range of motion of eye-tracking (in millimetres) in patients
Time Frame: one year
|
determination of the maximum range of motion of eye-tracking (in millimetres) in patients
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Study Registration Dates
First Submitted
October 12, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (Actual)
October 14, 2022
Study Record Updates
Last Update Posted (Actual)
May 28, 2025
Last Update Submitted That Met QC Criteria
May 22, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2021_843_0207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.