Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation
Recruiting now
Conditions studied: Muscular Dystrophy, Facioscapulohumeral
In brief
Facioscapulohumeral dystrophy (FSHD) is one of the most common hereditary neuromuscular disorders (NMD), with an estimated prevalence of 2000 patients in the Netherlands. Magnetic resonance imaging (MRI) and muscle ultrasound have contributed to an enhanced understanding of the pathophysiology of Facioscapulohumeral Muscular Dystrophy (FSHD). Previously, our group demonstrated the potential presence of an intermediate factor between muscle fiber loss and clinical weakness in FSHD. The influence of disrupted muscle architecture in FSHD on muscle contractile efficiency is a likely candidate for this factor, and remains relatively unexplored. In this study, we aim to assess the use of ultrasound-defined contractile performance, in comparison with current measures including structural MRI, for monitoring disease progression in FSHD.
Key facts
- Study ID
- NCT06227182
- Run by
- Radboud University Medical Center
- People needed
- 100
- Starts
- 2024-04-10
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2025-01-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age between 18 and 70 years.
- Informed consent is given by the participant.
- Ability to read and understand written and spoken instruction in Dutch.
- Willingness and ability to understand nature and content of the study
You may not qualify if…
- BMI ≥ 35
- Other diseases that could diffusely affect muscle integrity or disturb the imaging appearance beyond that what can be extrapolated.
- Wheelchair dependence
- Pregnancy
- Stage II: Any contra-indications for MRI, including:
- Claustrophobia
- Pacemakers and defibrillators
- Nerve stimulators
- Intracranial clips
- Intraorbital or intraocular metallic fragments
- Cochlear implants and ferromagnetic implants (e.g. implant for scoliosis)
- Inability to lie supine for 60 minutes
- Necessity of (continuous) daytime ventilation
- Scoliosis surgery
Where it is running
- Radboud university medical center — Nijmegen, Gelderland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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