Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.

Facial Palsy Clinical Trial

— EyeTrackingFP  

Official title:

Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04886245
• Other study ID #: PI2019_843_0089
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Stéphanie DAKPE, PR
• Phone: 03.22.08.90.50
• Email: dakpe.stephanie[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The facial palsy concerns between 15 and 40 people per 100000 inhabitants. They are of various etiologies such as infectious, tumoral, traumatic or idiopathic.

It has variable severities with sometimes heavy functional repercussions and different recovery potentials. The proposed palliative 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. In this context, patients' expectations and feelings about their care may become difficult for clinicians to apprehend.

The eye-tracking is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular. Published studies focus on the gaze of photographs, excluding any notion of dynamics and by the analysis of the gaze of outside observers, ignoring the patient's gaze.The main objective is to evaluate the attention paid to the facial side with abnormal facial movement by patients with facial paralysis compared to healthy volunteers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• for patient with facial paralysis:

• Patient with peripheral facial palsy, irrespective of grade, whether or not previously treated

• Patient providing written informed consent

• Patient aged = 18 years

• Patient affiliated to a social security system

• for Healthy voluntary subject :

• Subject without major facial sequelae

• Subject who provided written informed consent

• Major subject = 18 years old

• Subject affiliated to a social security system

Exclusion Criteria:

• for Patient with facial paralysis:

• Patient with recent peripheral facial palsy whose total recovery is possible

• Patient unable to provide written informed consent

• Patient with difficulties to follow instructions and especially to stand in front of a computer screen

• Minor patient <18 years

• Patient under guardianship or curators or judicial safeguard

• for Healthy voluntary subject :

• Subject with major facial sequelae

• Subject not able to provide written informed consent

• Subject presenting difficulties in following instructions and in particular in standing still in front of a computer screen

• Minor subject < 18 years old

• Subject under guardianship or curators or judicial safeguard

Related Conditions & MeSH terms

• Bell Palsy
• Eye-tracking
• Facial Palsy
• Facial Paralysis
• Facies
• Paralysis

Intervention

Other:
• Video sequences
videos will be made of each participant, during the realization of 5 movements that are the simple closure of the eyelids, the forced closure of the eyelids, the labial protrusion on the sound [o], the labial protrusion on the sound [pu] and the wide smile uncovering the teeth. Then, a video sequence will be realized thanks to the dedicated software Tobii Pro Lab®.

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

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	Variation of facial fixation day number between facial palsy patients and healthy volunteers		30 days
Primary	Incidence of facial movement abnormality between facial palsy patients and healthy volunteers		30 days