Comparing MRI and Ultrasound for Evaluating Muscle Function in Facioscapulohumeral Dystrophy
Ultrasound and Magnetic Resonance Imaging for Assessing Muscle Contractile Performance in FSHD - An Exploratory Study
This study is testing whether ultrasound and MRI can help us understand how muscle function is affected in people with Facioscapulohumeral Dystrophy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06227182 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of muscle ultrasound and MRI to assess contractile performance in patients with Facioscapulohumeral Dystrophy (FSHD). It aims to explore how disrupted muscle architecture affects muscle efficiency and to establish ultrasound-defined contractile performance as a potential biomarker for monitoring disease progression. Participants will undergo muscle ultrasound, surface electromyography, dynamometry, and MRI scans to gather comprehensive data on muscle function. The findings could enhance understanding of FSHD and improve monitoring methods for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 diagnosed with Facioscapulohumeral Dystrophy who can provide informed consent and understand the study's requirements.
Not a fit: Patients who are wheelchair-dependent, pregnant, or have contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker for tracking disease progression in patients with FSHD, leading to better management and treatment strategies.
How similar studies have performed: While muscle imaging has been used in other neuromuscular disorders, this specific approach to assess contractile performance in FSHD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Nijmegen, Gelderland
- Radboud university medical center — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nens Van Alfen, MD. PhD. — Radboud University Medical Center
- Study coordinator: Odette Van Iersel, MSc
- Email: Odette.vaniersel@radboudumc.nl
- Phone: 0243611111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.