Ultrasound Detection of Early Facial Muscle Changes in FSHD: Thickness and Echo Intensity Findings
FACIAL-FSHD
FACIAL-FSHD
Sponsor study identifier
Secondary identifiers
OTHER · Koç University Institutional Review Board
observational
39
1 country
1
Study Start
September 1, 2023
Actual (reported)Primary Completion
December 20, 2023
Actual (reported)Study Completion
February 15, 2024
Actual (reported)Facioscapulohumeral muscular dystrophy (FSHD) is characterized by early and significant involvement of facial muscles; however, objective imaging data focusing on facial muscles are limited. Facial ultrasound can serve as a sensitive imaging biomarker and outcome measure by capturing regional structural changes in facial muscles associated with disease progression in FSHD patients. The aim of this study is to compare facial muscle thickness and echo density between FSHD patients and healthy controls using ultrasound and to examine the relationships between ultrasound findings and clinical parameters. This study will include 20 patients with genetically confirmed FSHD1 diagnosis and 19 age- and sex-matched healthy controls. Using musculoskeletal ultrasound, bilateral evaluation of selected facial muscles (Orbicularis oculi, orbicularis oris, zygomaticus major, and buccinator) will be performed by two different researchers, and muscle thickness and muscle echo density will be recorded. Inter-rater reliability will be assessed using intraclass correlation coefficients. Group comparisons and correlation analyses will be performed with clinical scores, symptom duration, and D4Z4 repeat size. The results will evaluate whether ultrasound can reliably detect structural changes in FSHD that cannot be captured by traditional clinical assessments, and if significant, will suggest that ultrasound can serve as a sensitive imaging biomarker for early and region-specific facial muscle involvement in FSHD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2023
Actual (reported)December 20, 2023
Actual (reported)February 15, 2024
Actual (reported)December 17, 2025
Actual (reported)January 9, 2026
Actual (reported)Facial muscle thickness measured by ultrasound
Bilateral thickness (in millimeters) of the orbicularis oculi, orbicularis oris (superficial and deep layers), zygomaticus major, and buccinator muscles measured using B-mode musculoskeletal ultrasound at standardized anatomical reference points.
Baseline
Facial muscle echo intensity
Muscle echogenicity of the same facial muscles assessed bilaterally using the Modified Heckmatt Scale (grades 1-4) to evaluate structural changes and fatty infiltration on B-mode ultrasound images.
Baseline
Inter-rater reliability of facial muscle ultrasound measurements
Individuals with genetically confirmed facioscapulohumeral muscular dystrophy type 1 who underwent bilateral facial muscle ultrasound assessment. No intervention was applied.
Age- and sex-matched healthy volunteers without neuromuscular disease.
The study population consisted of adults with genetically confirmed facioscapulohumeral muscular dystrophy type 1 and age- and sex-matched healthy volunteers. Participants were recruited from a tertiary neuromuscular disease center and underwent a single-session bilateral facial muscle ultrasound assessment.
Koç University Hospital
Istanbul, Istanbul, 34010, Turkey (Türkiye)
Havvanur Albayrak
Koç University School of Medicine
39 participants (actual enrollment reported by the registry).
First Submitted
December 17, 2025
First Posted
January 9, 2026
Study Start
September 1, 2023
Actual (reported)Unraveling Metabolic Involvement in Facioscapulohumeral Dystrophy Through Metabolomics
Baseline
Contact the study team to confirm eligibility.
Primary Completion
December 20, 2023
Actual (reported)Study Completion
February 15, 2024
Actual (reported)Last Updated
January 9, 2026
Record last verified: 2025-12
Individual participant data will not be shared due to the small sample size, the rare disease nature of the study population, and the potential risk of participant re-identification. In addition, specific informed consent for public data sharing was not obtained.
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