ElectromyographyAQ2MFNCT05581680
Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological and Control Subjects
A study testing dental impressions, Simultaneous MoCap and EMG acquisition and Eye-tracking acquisition for pathological subjects in people with Electromyography and Eye-tracking, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electromyography, Eye-tracking, Facial Palsy
- What is being tested?
- dental impressions, Simultaneous MoCap and EMG acquisition and Eye-tracking acquisition for pathological subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2022to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Stéphanie DAKPE, Dr, +33322668322, dakpe.stephanie@chu-amiens.fr
François-Régis Sarhan, DR
About this study
Official title: 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.
- Conditions
- Electromyography, Eye-tracking, Facial Palsy
- Being tested
- dental impressions, Simultaneous MoCap and EMG acquisition, Eye-tracking acquisition for pathological subjects, Follow-up visit for pathological subjects
- Keywords
- facial mimics, motion capture, electromyography, eye-tracking, Facial Palsy
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental impressionsOther
dental impressions
Simultaneous MoCap and EMG acquisitionOther
Simultaneous MoCap and EMG acquisition
Eye-tracking acquisition for pathological subjectsOther
Eye-tracking acquisition for pathological subjects
Follow-up visit for pathological subjectsOther
Follow-up visit for pathological subjects
| Study group | Role | What they receive |
|---|---|---|
| patients with facial palsy | Experimental | Not described Receives: Other: dental impressions; Other: Simultaneous MoCap and EMG acquisition; Other: Eye-tracking acquisition for pathological subjects; Other: Follow-up visit for pathological subjects |
| healthy volunteers | Active comparator | Not described Receives: Other: dental impressions; Other: Simultaneous MoCap and EMG acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers
Measured: one month
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
determination of baseline values of eye-tracking (in millimetres) in healthy volunteers
Measured: one month
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
Measured: one year
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start12 Oct 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectromyographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581680
- Sponsor's protocol ID
- PI2021_843_0207
- Acronym
- AQ2MF
- Status last verified
- May 2025
- First submitted
- 12 Oct 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological
- ClinicalTrials.gov ID
- NCT05581680
- Acronym / sponsor ID
- AQ2MF / PI2021_843_0207
- Conditions
- Electromyography, Eye-tracking, Facial Palsy
- Keywords
- facial mimics, motion capture, electromyography, eye-tracking, Facial Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with facial palsy | Experimental | Other: dental impressions, Other: Simultaneous MoCap and EMG acquisition, Other: Eye-tracking acquisition for pathological subjects, Other: Follow-up visit for pathological subjects |
| healthy volunteers | Active comparator | Other: dental impressions, Other: Simultaneous MoCap and EMG acquisition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental impressionsdental impressions | Other | healthy volunteers, patients with facial palsy |
| Simultaneous MoCap and EMG acquisitionSimultaneous MoCap and EMG acquisition | Other | healthy volunteers, patients with facial palsy |
| Eye-tracking acquisition for pathological subjectsEye-tracking acquisition for pathological subjects | Other | patients with facial palsy |
| Follow-up visit for pathological subjectsFollow-up visit for pathological subjects | Other | patients with facial palsy |
Primary outcome
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental impressions, Simultaneous MoCap and EMG acquisition and Eye-tracking acquisition for pathological subjects in people with Electromyography and Eye-tracking, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Dakpé, Pr (03 22 08 90 50, dakpe.stephanie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of baseline values of facial mimicry (in millimetres) in healthy volunteers (time frame: one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.