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

NCT ID: NCT04886245

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-06

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Eye-tracking Facial Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

facial palsy

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

Group Type EXPERIMENTAL

Video sequences

Intervention Type OTHER

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®.

healthy volunteers

\- Subject without major facial sequelae

Group Type SHAM_COMPARATOR

Video sequences

Intervention Type OTHER

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®.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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®.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stéphanie DAKPE, PR

Role: CONTACT

03.22.08.90.50

Sylvie TESTELIN

Role: CONTACT

03.22.08.90.50

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Stéphanie DAKPE, Pr

Role: primary

03.22.08.90.50

Sylvie Testellin, Pr

Role: backup

03 22 08 90 50

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI2019_843_0089

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Visual Rehabilitation After Occipital Stroke
NCT04798924 ACTIVE_NOT_RECRUITING NA