AQ2MF: Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological and Control Subjects

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05581680
• Collaborator: (none)
• Enrollment: 720
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 71.7
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Electromyography; Eye-tracking; Facial Palsy	Other: dental impressions; Other: Simultaneous MoCap and EMG acquisition; Other: Eye-tracking acquisition for pathological subjects; Other: Follow-up visit for pathological subjects	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 720 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Multimodal Quantified Analysis of Facial Movements: Comparison Between Pathological
• Actual Study Start Date: Oct 12, 2022
• Anticipated Primary Completion Date: Oct 1, 2027
• Anticipated Study Completion Date: Oct 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with facial palsy	Other: dental impressions; dental impressions; Other: Simultaneous MoCap and EMG acquisition; Simultaneous MoCap and EMG acquisition; Other: Eye-tracking acquisition for pathological subjects; Eye-tracking acquisition for pathological subjects; Other: Follow-up visit for pathological subjects; Follow-up visit for pathological subjects
Active Comparator: healthy volunteers	Other: dental impressions; dental impressions; Other: Simultaneous MoCap and EMG acquisition; Simultaneous MoCap and EMG acquisition

Outcome Measures

Primary Outcome Measures

1. determination of baseline values of facial mimicry (in millimetres) in healthy volunteers [one month]

   determination of baseline values of facial mimicry (in millimetres) in healthy volunteers

2. determination of baseline values of eye-tracking (in millimetres) in healthy volunteers [one month]

   determination of baseline values of eye-tracking (in millimetres) in healthy volunteers

3. determination of the maximum range of motion of facial mimicry (in millimetres) in patients [one year]

   determination of the maximum range of motion facial mimicry (in millimetres) in patients

4. determination of the maximum range of motion of eye-tracking (in millimetres) in patients [one year]

   determination of the maximum range of motion of eye-tracking (in millimetres) in patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens	Picardie	France	80054

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT05581680
• Other Study ID Numbers: PI2021_843_0207
• First Posted: Oct 14, 2022
• Last Update Posted: Oct 27, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire, Amiens: facial mimics; motion capture; electromyography; eye-tracking; Facial Palsy
• Additional relevant MeSH terms: Bell Palsy; Facial Paralysis; Facies

Study Results

No Results Posted as of Oct 27, 2022