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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05581680
Other study ID # PI2021_843_0207
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 12, 2022
Est. completion date October 2028

Study information

Verified date October 2022
Source Centre Hospitalier Universitaire, Amiens
Contact Stéphanie Dakpé, Pr
Phone 03 22 08 90 50
Email dakpe.stephanie@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date October 2028
Est. primary completion date October 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
dental impressions
dental impressions
Simultaneous MoCap and EMG acquisition
Simultaneous MoCap and EMG acquisition
Eye-tracking acquisition for pathological subjects
Eye-tracking acquisition for pathological subjects
Follow-up visit for pathological subjects
Follow-up visit for pathological subjects

Locations

Country Name City State
France CHU Amiens Picardie Amiens Picardie

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary determination of baseline values of facial mimicry (in millimetres) in healthy volunteers determination of baseline values of facial mimicry (in millimetres) in healthy volunteers one month
Primary determination of baseline values of eye-tracking (in millimetres) in healthy volunteers determination of baseline values of eye-tracking (in millimetres) in healthy volunteers one month
Primary 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 one year
Primary 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 one year
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