Back to results

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

Primary Purpose

Eye-tracking, Facial Palsy

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Video sequences

About this trial

This is an interventional supportive care trial for Eye-tracking focused on measuring facial mimics, eye-tracking, Facial Palsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

facial palsy

healthy volunteers

Arm Description

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

- Subject without major facial sequelae

Outcomes

Primary Outcome Measures

Variation of facial fixation day number between facial palsy patients and healthy volunteers

Incidence of facial movement abnormality between facial palsy patients and healthy volunteers

Secondary Outcome Measures

Full Information

NCT ID

NCT04886245

First Posted

May 7, 2021

Last Updated

February 9, 2023

Sponsor

Centre Hospitalier Universitaire, Amiens

1. Study Identification

Unique Protocol Identification Number

NCT04886245

Brief 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.

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 6, 2021 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eye-tracking, Facial Palsy

Keywords

facial mimics, eye-tracking, Facial Palsy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

facial palsy

Arm Type

Experimental

Arm Description

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

Arm Title

healthy volunteers

Arm Type

Sham Comparator

Arm Description

- Subject without major facial sequelae

Intervention Type

Other

Intervention Name(s)

Video sequences

Intervention Description

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®.

Primary Outcome Measure Information:

Title

Variation of facial fixation day number between facial palsy patients and healthy volunteers

Time Frame

30 days

Title

Incidence of facial movement abnormality between facial palsy patients and healthy volunteers

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stéphanie DAKPE, PR

Phone

03.22.08.90.50

dakpe.stephanie@chu-amiens.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sylvie TESTELIN

Phone

03.22.08.90.50

testelin.sylvie@chu-amiens.fr

Facility Information:

Facility Name

CHU Amiens

City

Amiens

ZIP/Postal Code

80480

Country

France

Individual Site Status

Recruiting

Facility Contact: