NCT04886245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 7, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

May 7, 2021

Last Update Submit

February 9, 2023

Conditions

Eye-trackingFacial Palsy

Keywords

facial mimicseye-trackingFacial Palsy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

facial palsy

EXPERIMENTAL

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

Other: Video sequences

healthy volunteers

SHAM COMPARATOR

\- Subject without major facial sequelae

Other: Video sequences

Interventions

Video sequencesOTHER

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®.

facial palsyhealthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Stéphanie DAKPE, PR

CONTACT

03.22.08.90.50dakpe.stephanie@chu-amiens.fr

Sylvie TESTELIN

CONTACT

03.22.08.90.50testelin.sylvie@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 14, 2021

Study Start

May 6, 2021

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)