- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04886245
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stéphanie DAKPE, Pr
- Phone Number: 03.22.08.90.50
- Email: dakpe.stephanie@chu-amiens.fr
Study Contact Backup
- Name: Sylvie TESTELIN
- Phone Number: 03.22.08.90.50
- Email: testelin.sylvie@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80480
- Recruiting
- CHU Amiens
-
Contact:
- Sylvie Testellin, Pr
- Phone Number: 03 22 08 90 50
- Email: testelin.sylvie@chu-amiens.fr
-
Sub-Investigator:
- Luc VANDROMME, Pr
-
Contact:
- Stéphanie DAKPE, Pr
- Phone Number: 03.22.08.90.50
- Email: dakpe.stephanie@chu-amiens.fr
-
Sub-Investigator:
- Bernard DEVAUCHELLE, Pr
-
Sub-Investigator:
- Federica CILIA, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2019_843_0089
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Centre Hospitalier Universitaire de NiceRecruitingPeripheral Facial PalsyFrance
-
Rebecka OhmRecruitingFacial Palsy | Bell Palsy | Facial Paralysis | Synkinesis | Peripheral Facial Palsy | Peripheral Facial ParalysisSweden
-
Assiut UniversityCompleted
-
Lama Saad El-Din MahmoudCompletedBell's Palsy | Facial Nerve PalsyEgypt
-
Centre Hospitalier Universitaire, AmiensUniversity Hospital, RouenRecruitingRehabilitation | Virtual Reality | Peripheral Facial PalsyFrance
-
Riphah International UniversityCompleted
-
Kantonsspital AarauETH ZurichCompleted
-
Uniter OnlusUniversity of Rome Tor VergataCompleted
-
Assiut UniversityCompleted
-
Zhuan ZhangCompletedPeripheral Facial PalsyChina
Clinical Trials on Video sequences
-
Assistance Publique - Hôpitaux de ParisCompletedDigestive InflammationFrance
-
GE HealthcareCompletedClinical Indication for a Head MRIUnited States
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
University Hospital, AngersUniversity AngersRecruitingNon-alcoholic Fatty Liver Disease NAFLDFrance
-
King's College Hospital NHS TrustKing's College London; Erasmus Medical CenterNot yet recruiting
-
CNAO National Center of Oncological HadrontherapyDept. of Electronics, Informatics, Bioengineering, Politecnico di Milano,...Recruiting
-
Fondation Ophtalmologique Adolphe de RothschildCompletedPre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO) (I-RECANAL)Magnetic Resonance Imaging | Diagnosis | Prognosis | Retinal Artery Occlusion | EtiologyFrance
-
Great Ormond Street Hospital for Children NHS Foundation...CompletedCerebellar Mutism | Posterior Fossa SyndromeUnited Kingdom
-
Fondation Ophtalmologique Adolphe de RothschildRecruitingDescription of Local Modifications of Lymph Nodes or Bundles With the FABIR Sequence in MRIFrance