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)

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Amiens, France, 80480
        • Recruiting
        • CHU Amiens
        • Contact:
        • Sub-Investigator:
          • Luc VANDROMME, Pr
        • Contact:
        • Sub-Investigator:
          • Bernard DEVAUCHELLE, Pr
        • Sub-Investigator:
          • Federica CILIA, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: facial palsy
Patient with peripheral facial palsy, irrespective of grade, whether or not previously treated

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

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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of facial fixation day number between facial palsy patients and healthy volunteers
Time Frame: 30 days
30 days
Incidence of facial movement abnormality between facial palsy patients and healthy volunteers
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Facial Palsy

Clinical Trials on Video sequences

Subscribe