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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04886245

Collaborator

(none)

Enrollment

Location

Arms

24.8

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Eye-tracking Facial Palsy	Other: Video sequences	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

May 6, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: facial palsy Patient with peripheral facial palsy, irrespective of grade, whether or not previously treated	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®.
Sham Comparator: healthy volunteers - Subject without major facial sequelae	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®.

Arm

Intervention/Treatment

Experimental: facial palsy

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

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®.

Sham Comparator: healthy volunteers

- Subject without major facial sequelae

Other: Video sequences

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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