Multiparametric Ultrafast Ultrasound Biomarkers for Duchenne and Becker Muscular Dystrophies

NCT07378553 | Not Yet Recruiting

• 2 other identifiers: RC25_02732025-A01398-41
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to determine the potential of a multiparametric ultrasound approach to non-invasively monitor disease progression and to serve as an objective outcome measure for future clinical trials in Duchenne and Becker Muscular Dystrophies. The investigators will compare the muscles of ambulatory or non-ambulatory boys/men with Duchenne and Becker Dystrophies with muscles of healthy age-matched individuals of the same age and monitor disease progression in those with muscular dystrophies over a 12-month year period. The ultrafast ultrasound technology used in this study allows the simultaneous assessment of muscle structure, mechanics and physiology, including stiffness, anisotropy, viscosity, intramuscular fat, muscle volume, and microvascular perfusion. The amount of muscle alteration measured will be related to performance in daily activities, such as walking and muscle strength, in order to identify sensitive and objective markers of disease progression.

Conditions

Duchene Muscular Dystrophy; Becker Muscular Dystrophy

Keywords

Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Ultrasound Imaging; Ultrafast Ultrasound; Muscle

Outcome Measures

Primary Outcomes (6)

• Baseline mechanical, structural, and physiological muscle ultrasound parameters

  Assessment of muscle stiffness (kPa) in the lower extremity and/or upper extremity muscles across three participant groups

  Baseline

• Baseline mechanical, structural, and physiological muscle ultrasound parameters

  Assessment of anisotropy (a.u.) in the lower extremity and/or upper extremity muscles across three participant groups

  Baseline

• Baseline mechanical, structural, and physiological muscle ultrasound parameters

  Assessment of viscosity (Np/mm) in the lower extremity and/or upper extremity muscles across three participant groups

  Baseline

• Baseline mechanical, structural, and physiological muscle ultrasound parameters

  Assessment of nonlinear elastic parameters (kPa) in the lower extremity and/or upper extremity muscles across three participant groups

  Baseline

• Baseline mechanical, structural, and physiological muscle ultrasound parameters

  Assessment of intramuscular fat (m/s) in the lower extremity and/or upper extremity muscles across three participant groups

  Baseline

• Baseline mechanical, structural, and physiological muscle ultrasound parameters

  Assessment of intramuscular blood flow (%) in the lower extremity and/or upper extremity muscles across three participant groups

  Baseline

Secondary Outcomes (10)

• Change from baseline in mechanical, structural, and physiological muscle ultrasound parameters

  12 months

• Change from baseline in mechanical, structural, and physiological muscle ultrasound parameters

  12 months

• Change from baseline in mechanical, structural, and physiological muscle ultrasound parameters

  12 months

• Change from baseline in mechanical, structural, and physiological muscle ultrasound parameters

  12 months

• Change from baseline in mechanical, structural, and physiological muscle ultrasound parameters

  12 months

Study Arms (3)

Age-matched Controls

Age matched non-affected men, matched for men with Becker and Duchenne Muscular Dystrophies

Boys/Men with Duchenne Muscular Dystrophy

This group will include ambulatory and non-ambulatory boys/men with Duchenne Muscular Dystrophy ranging from 5-30 years old.

Boys/Men with Becker Muscular Dystrophy

This group will include ambulatory and non-ambulatory men with Becker Muscular Dystrophy ranging from 5-60 years old.

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study Population This bicentric study will include 60 participants: 18 male patients with Duchenne Muscular Dystrophy (DMD), aged 5 to 30 years (ambulant and non-ambulant), 18 male patients with Becker Muscular Dystrophy (BMD), aged 5 to 60 years, and 24 healthy male subjects, aged 5 to 60 years, without neuromuscular disease or limb injury. All participants must have French social insurance coverage and provide informed consent (from parents or legal representatives for minors). Patients will be recruited mainly from the CHU de Nantes, the Institut de Myologie (Paris), and through the French Muscular Dystrophy Association (AFM-Téléthon). Healthy volunteers will be recruited from Nantes University staff, students, and their children. The inclusion of minors is necessary because Duchenne and Becker muscular dystrophies are X-linked genetic disorders diagnosed in childhood, and disease severity increases with age.

You may not qualify if:

• Inability to undergo static exam, missing measurement site (resection/amputation), neurocognitive impairment preventing informed consent

Sponsors & Collaborators

• Nantes University Hospital: lead
• AGENCE NATIONALE DE RECHERCHE: collaborator

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 30, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 30, 2026

Record last verified: 2025-11