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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04377217
Other study ID # 18-AOI-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2019
Est. completion date July 25, 2019

Study information

Verified date November 2023
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 25, 2019
Est. primary completion date July 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Video recording
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.

Locations

Country Name City State
France Hopital Pasteur 2 Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Video recording Sensitivity and specificity of the algorithm to differentiate FSMHD patients with moderate and severe facial impairment from control subjects fisrt day
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