Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video sequences.
- Who it may be relevant to
- Registry conditions: Eye-tracking, Facial Palsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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®.
Primary outcome measures
- Variation of facial fixation day number between facial palsy patients and healthy volunteers [Time frame: 30 days]
- Incidence of facial movement abnormality between facial palsy patients and healthy volunteers [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04886245 · PI2019_843_0089