Computerized Facial Recognition for Automated Diagnosis of the Facio-Scapulo-Humeral Muscular Dystrophy (FSMHD) (CV4DIAGNOSIS)
Primary Purpose
Facio-Scapulo-Humeral Dystrophy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Video recording
Sponsored by
About this trial
This is an interventional diagnostic trial for Facio-Scapulo-Humeral Dystrophy
Eligibility Criteria
- Patient belonging to one of these four groups:
- Group 1 FSMHD confirmed or to be confirmed with moderate facial involvement
- Group 2 FSMHD confirmed or to be confirmed with severe facial involvement.
- Group 3 Other disease NM confirmed or to be confirmed.
- Group 4 control subjects.
Exclusion Criteria:
- Patient presenting all pathologies judged by the investigator to interfere with the smooth running of the study (facial trauma, ...).
- Pregnant or breastfeeding women of childbearing age.
Sites / Locations
- Hopital Pasteur 2Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Video recording
Arm Description
The experimenter will make a standardized video of the patient during the inclusion process, and a second one after 18 months.
Outcomes
Primary Outcome Measures
Video recording
Sensitivity and specificity of the algorithm to differentiate FSMHD patients with moderate and severe facial impairment from control subjects
Secondary Outcome Measures
Full Information
NCT ID
NCT04377217
First Posted
May 2, 2020
Last Updated
August 25, 2020
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04377217
Brief Title
Computerized Facial Recognition for Automated Diagnosis of the Facio-Scapulo-Humeral Muscular Dystrophy (FSMHD)
Acronym
CV4DIAGNOSIS
Official Title
Computerized Facial Recognition for Automated Diagnosis of the Facio-Scapulo-Humeral Muscular Dystrophy (FSMHD): Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The clinical diagnosis of Facio-Scapulo-Humeral Muscular Dystrophy (FSHMD) requires the movement of patients to a medical centre and a lengthy examination involving medical personnel, and may be underestimated in the most moderate cases. Thus, it requires costly and burdensome logistics both for patients living in remote areas and having to undertake long and expensive travel, and for clinical staff. This is an obstacle to large-scale diagnosis. The investigators plan to alleviate these limitations through the use of digital facial analysis technology that would enable large-scale diagnosis of patients through telemedicine.
Motivated by the reasons described above and by preliminary results, the goal of this project is to develop methods to automatically detect and monitor the progression of this disease using computer vision algorithms. In order to do this, the investigators will first build up a bank of images and videos of patients with moderate to severe FSHMD, patients with other muscular dystrophies causing facial muscle asymmetry, as well as control subjects without facial involvement. Each of these subjects will be characterized clinically and genetically.
The investigators will then develop computer tools using video and audio sensors capable of detecting facial muscle damage in patients with FSHMD and differentiating them from control subjects on the one hand and patients with other muscular dystrophies on the other hand. The investigators wish to use the most recent advances in terms of "deep-learning" and improve their architecture in order to achieve our objectives.
In addition to this holistic approach, the investigators will study facial recognition approaches capable of accurately identifying different facial areas on images, as well as the relevance of different statistical properties of facial dynamics (duration and intensity). These algorithms will also be useful for monitoring the evolution of facial damage in order to develop a specific measurement tool that could be used in patient follow-up and in clinical trials on early stages of the disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facio-Scapulo-Humeral Dystrophy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Video recording
Arm Type
Experimental
Arm Description
The experimenter will make a standardized video of the patient during the inclusion process, and a second one after 18 months.
Intervention Type
Other
Intervention Name(s)
Video recording
Intervention Description
The experimenter will make a standardized video of the patient during the inclusion process, and a second one after 18 months, in order to evaluate the evolution of facial damage. Then algorithms will be developped to be able of differentiating FSHMD patients with facial damage from control subjects using video and audio recordings.
Primary Outcome Measure Information:
Title
Video recording
Description
Sensitivity and specificity of the algorithm to differentiate FSMHD patients with moderate and severe facial impairment from control subjects
Time Frame
fisrt day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
- Patient belonging to one of these four groups:
Group 1 FSMHD confirmed or to be confirmed with moderate facial involvement
Group 2 FSMHD confirmed or to be confirmed with severe facial involvement.
Group 3 Other disease NM confirmed or to be confirmed.
Group 4 control subjects.
Exclusion Criteria:
Patient presenting all pathologies judged by the investigator to interfere with the smooth running of the study (facial trauma, ...).
Pregnant or breastfeeding women of childbearing age.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luisa VILLA, Dr
Phone
492038729
Ext
+33
Email
villa.l@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luisa VILLA, Dr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Pasteur 2
City
Nice
ZIP/Postal Code
06001
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luisa VILLA, Dr
Phone
492038729
Ext
+33
Email
villa.l@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Computerized Facial Recognition for Automated Diagnosis of the Facio-Scapulo-Humeral Muscular Dystrophy (FSMHD)
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