Muscular Dystrophy, FacioscapulohumeralMUSCLE+NCT06227182
Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation
An observational study of Muscular Dystrophy, Facioscapulohumeral, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Dystrophy, Facioscapulohumeral
- What is being tested?
- Muscle ultrasound with surface electromyography and dynamometry and MRI scan
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Apr 2024to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In the Netherlands, FSHD has an estimated prevalence of 2000 patients. All patients will be recruited from one of the largest longitudinal follow up database, FSHD-FOCUS, which is maintained at the Dutch Radboudumc expertise center. This FSHD-FOCUS cohortwas started in 2014 and includes around 200 patients with clinically and genetically proven FSHD type 1 and type 2. A 5-year-follow-up study (FSHD-FOCUS2) collected comprehensive data on the natural course of FSHD using multiple clinical outcome measures. Only patients who have given consent during the FSHD-FOCUS study to be contacted for subsequent research, will be contacted for this study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland
Odette Van Iersel, MSc, 0243611111, Odette.vaniersel@radboudumc.nl
Jonne Doorduin, PhD, 0243611111, Jonne.Doorduin@radboudumc.nl
About this study
Official title: Ultrasound and Magnetic Resonance Imaging for Assessing Muscle Contractile Performance in FSHD - An Exploratory Study
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.
Read the detailed description
Rationale: Facioscapulohumeral dystrophy (FSHD) is a slowly progressive hereditary muscle dystrophy characterized by initial asymmetrical weakness of the facial and shoulder girdle muscles, frequently followed by weakness in the trunk and leg muscles.
Previously, our research group showed 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. However, there is currently still a lack of studies on how the disrupted muscle architecture in muscle dystrophies influences the contractile efficiency. We might establish a baseline for muscle contractile performance with muscle ultrasound, determined by muscle strain and displacement.
Muscle imaging has previously contributed to a better understanding of the pathophysiology of various neuromuscular disorders. Both MRI and ultrasound have proven their clinical relevance in neuromuscular dystrophy. With the current development of FSHD clinical trials, the extensive need for biomarkers to follow disease progression is growing. To investigate whether muscle contractile performance can help explain the loss in strength and thereby also has the potential to act as a future biomarker, will be explored in this project.
Objective(s): We aim to assess the use of ultrasound-defined contractile performance as a biomarker for monitoring disease progression and treatment effects in patients with FSHD.
Stage I:
To establish the feasibility, optimal protocol, and repeatability of quantifying ultrasound-defined muscle contractile performance in the upper and lower limb muscles in healthy volunteers and patients with FSHD.
Stage II:
- To determine the differences in ultrasound-defined contractile performance between healthy individuals and patients with FSHD, and compare to conventional clinical measures, ultrasound measures and MRI measures.
- To determine the responsiveness of ultrasound-defined contractile performance to disease progression in FSHD patients after 1 year, and compare to MRI measures and other ultrasound measures.
Study design: This prospective cohort study consists of two different stages. In Stage I, the feasibility and repeatability of quantifying ultrasound-defined muscle contractile performance will be assessed in 15 healthy volunteers and 10 patients with FSHD type 1 or 2. Each participant in stage I has to visit the hospital only once. In Stage II, the ultrasound-defined contractile performance, and other ultrasound and MRI outcome measures of healthy volunteers and FSHD patients (type 1 or 2) are compared. In addition, the responsiveness of the different measurements to disease progression after 1 year will be analyzed only in FSHD patients. 50 patients with FSHD will perform these measurements of stage II during the two scheduled visits at baseline (T0) and the two scheduled visits 1-year after the first visit. In stage II, 25 Healthy volunteers will be recruited and will undergo the muscle ultrasound assessment. Only 10 out of 25 healthy volunteers will also undergo the MRI measurements. None of the healthy volunteers will perform follow-up measurements after 1 year. Therefore, 15 healthy volunteers will perform the ultrasound assessment of stage II during 1 visit and 10 healthy volunteers will perform ultrasound measurements during visit 1 and MRI measurements during visit 2 at baseline. A total of 100 individuals will participate in this study.
- Conditions
- Muscular Dystrophy, Facioscapulohumeral
- Being tested
- Muscle ultrasound with surface electromyography and dynamometry, MRI scan
- Keywords
- Magnetic Resonance Imaging, Muscle Ultrasound
- Medical subject headings
- Muscular Dystrophy, Facioscapulohumeral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle ultrasound with surface electromyography and dynamometryDiagnostic test
The three procedures are conducted simultaneously for upper and lower extremity muscles. A standard muscle ultrasound preset with a fixed depth of 4 cm or 6 cm will be used, depending on which muscle is visualized in accordance with our routine clinical protocols. During the dynamic approach, the transducer will be placed in a longitudinal fixed position on the muscle using a ProbeFix. All measured contractions in the different muscles will be recorded as short ultrasound videos.
MRI scanDiagnostic test
In Stage II, all patients and 10 healthy participants will undergo MRI. During the MRI procedure, we evaluate muscle fat fraction, muscle contractile volume, muscle inflammation and edema.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Healthy individuals between 18 and 70 years old. Receives: Diagnostic Test: Muscle ultrasound with surface electromyography and dynamometry; Diagnostic Test: MRI scan | |
| Patients with FSHD | Individuals with clinically and genetically proven FSHD type 1 or type 2. Receives: Diagnostic Test: Muscle ultrasound with surface electromyography and dynamometry; Diagnostic Test: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage I: Repeatability and feasibility of the ultrasound-defined muscle contractile performance.
The feasibility of the ultrasound-defined contractile performance procedure is expressed in the number of dropouts in stage I. The repeatability of the muscle contractile performance procedure will be determined with the coefficient of variation in stage I.
Measured: At baseline
Stage II: Difference in contractile performance, MRI measures and clinical measures between healthy individuals and patients with FSHD.
The ultrasound Speckle-Tracking technique is employed during the dynamic approach to establish the muscle contractile performance, determined by muscle strain and displacement. The Ultrafast Shear Wave Elastography Imaging technique is used during the static approach to evaluate muscle stiffness, grey values(Z-scores) and muscle pinnation angle.
With the MRI measurements we evaluate the muscle fat fraction (%), contractile volume(mm^3), muscle edema, muscle inflammation, fiber curvature, fascicle length(mm), PCSA(mm^2).
Measured: At baseline
Stage II: Change of contractile performance, MRI measures and clinical measures with FSHD disease progression after 1 year.
The ultrasound, MRI and clinical measures at baseline are compared with the measures after 1 year.
The ultrasound Speckle-Tracking technique is employed during the dynamic approach to establish the muscle contractile performance, determined by muscle strain and displacement. The Ultrafast Shear Wave Elastography Imaging technique is used during the static approach to evaluate muscle stiffness, grey values(Z-scores) and muscle pinnation angle.
For FSHD patients in this study the Medical Research Counsel scale (MRC) and/or Ricci score will be known. These measures will also be used to evaluate disease progression. The range of the MRC score is 0-5, in which '0' means no contraction of the muscle and '5' means normal contraction of the muscle. The Ricci score ranges from 0 - 10 (0= no symptoms and 10=wheelchair bound).
With the MRI measurements we evaluate the muscle fat fraction (%), contractile volume(mm^3), fiber curvature, fascicle length(mm), PCSA(mm^2).
Measured: change from baseline to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start10 Apr 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular Dystrophy, FacioscapulohumeralStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Solve FSHD
- Responsible party
- Sponsor
- Investigators
- Nens Van Alfen, MD. PhD., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227182
- Sponsor's protocol ID
- NL84168.091.23
- Acronym
- MUSCLE+
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized (imaging) data will be made available in a suitable open-source online repository after the study results are published in peer-reviewed journals. A DOI will be assigned to dataset published in the Donders Data Repository (soon: Radboud Data Repository).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound and Magnetic Resonance Imaging for Assessing Muscle Contractile Performance in FSHD - An Exploratory Study
- ClinicalTrials.gov ID
- NCT06227182
- Acronym / sponsor ID
- MUSCLE+ / NL84168.091.23
- Conditions
- Muscular Dystrophy, Facioscapulohumeral
- Keywords
- Magnetic Resonance Imaging, Muscle Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Solve FSHD
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Facioscapulohumeral dystrophy (FSHD) is a slowly progressive hereditary muscle dystrophy characterized by initial asymmetrical weakness of the facial and shoulder girdle muscles, frequently followed by weakness in the trunk and leg muscles.
Previously, our research group showed 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. However, there is currently still a lack of studies on how the disrupted muscle architecture in muscle dystrophies influences the contractile efficiency. We might establish a baseline for muscle contractile performance with muscle ultrasound, determined by muscle strain and displacement.
Muscle imaging has previously contributed to a better understanding of the pathophysiology of various neuromuscular disorders. Both MRI and ultrasound have proven their clinical relevance in neuromuscular dystrophy. With the current development of FSHD clinical trials, the extensive need for biomarkers to follow disease progression is growing. To investigate whether muscle contractile performance can help explain the loss in strength and thereby also has the potential to act as a future biomarker, will be explored in this project.
Objective(s): We aim to assess the use of ultrasound-defined contractile performance as a biomarker for monitoring disease progression and treatment effects in patients with FSHD.
Stage I:
To establish the feasibility, optimal protocol, and repeatability of quantifying ultrasound-defined muscle contractile performance in the upper and lower limb muscles in healthy volunteers and patients with FSHD.
Stage II:
- To determine the differences in ultrasound-defined contractile performance between healthy individuals and patients with FSHD, and compare to conventional clinical measures, ultrasound measures and MRI measures.
- To determine the responsiveness of ultrasound-defined contractile performance to disease progression in FSHD patients after 1 year, and compare to MRI measures and other ultrasound measures.
Study design: This prospective cohort study consists of two different stages. In Stage I, the feasibility and repeatability of quantifying ultrasound-defined muscle contractile performance will be assessed in 15 healthy volunteers and 10 patients with FSHD type 1 or 2. Each participant in stage I has to visit the hospital only once. In Stage II, the ultrasound-defined contractile performance, and other ultrasound and MRI outcome measures of healthy volunteers and FSHD patients (type 1 or 2) are compared. In addition, the responsiveness of the different measurements to disease progression after 1 year will be analyzed only in FSHD patients. 50 patients with FSHD will perform these measurements of stage II during the two scheduled visits at baseline (T0) and the two scheduled visits 1-year after the first visit. In stage II, 25 Healthy volunteers will be recruited and will undergo the muscle ultrasound assessment. Only 10 out of 25 healthy volunteers will also undergo the MRI measurements. None of the healthy volunteers will perform follow-up measurements after 1 year. Therefore, 15 healthy volunteers will perform the ultrasound assessment of stage II during 1 visit and 10 healthy volunteers will perform ultrasound measurements during visit 1 and MRI measurements during visit 2 at baseline. A total of 100 individuals will participate in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Diagnostic Test: Muscle ultrasound with surface electromyography and dynamometry, Diagnostic Test: MRI scanHealthy individuals between 18 and 70 years old. |
| Patients with FSHD | – | Diagnostic Test: Muscle ultrasound with surface electromyography and dynamometry, Diagnostic Test: MRI scanIndividuals with clinically and genetically proven FSHD type 1 or type 2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In the Netherlands, FSHD has an estimated prevalence of 2000 patients. All patients will be recruited from one of the largest longitudinal follow up database, FSHD-FOCUS, which is maintained at the Dutch Radboudumc expertise center. This FSHD-FOCUS cohortwas started in 2014 and includes around 200 patients with clinically and genetically proven FSHD type 1 and type 2. A 5-year-follow-up study (FSHD-FOCUS2) collected comprehensive data on the natural course of FSHD using multiple clinical outcome measures. Only patients who have given consent during the FSHD-FOCUS study to be contacted for subsequent research, will be contacted for this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle ultrasound with surface electromyography and dynamometryThe three procedures are conducted simultaneously for upper and lower extremity muscles. A standard muscle ultrasound preset with a fixed depth of 4 cm or 6 cm will be used, depending on which muscle is visualized in accordance with our routine clinical protocols. During the dynamic approach, the transducer will be placed in a longitudinal fixed position on the muscle using a ProbeFix. All measured contractions in the different muscles will be recorded as short ultrasound videos. | Diagnostic test | Healthy individuals, Patients with FSHD |
| MRI scanIn Stage II, all patients and 10 healthy participants will undergo MRI. During the MRI procedure, we evaluate muscle fat fraction, muscle contractile volume, muscle inflammation and edema. | Diagnostic test | Healthy individuals, Patients with FSHD |
Primary outcome
Stage I: Repeatability and feasibility of the ultrasound-defined muscle contractile performance.
Time frame: At baseline
The feasibility of the ultrasound-defined contractile performance procedure is expressed in the number of dropouts in stage I. The repeatability of the muscle contractile performance procedure will be determined with the coefficient of variation in stage I.
Stage II: Difference in contractile performance, MRI measures and clinical measures between healthy individuals and patients with FSHD.
Time frame: At baseline
The ultrasound Speckle-Tracking technique is employed during the dynamic approach to establish the muscle contractile performance, determined by muscle strain and displacement. The Ultrafast Shear Wave Elastography Imaging technique is used during the static approach to evaluate muscle stiffness, grey values(Z-scores) and muscle pinnation angle. With the MRI measurements we evaluate the muscle fat fraction (%), contractile volume(mm^3), muscle edema, muscle inflammation, fiber curvature, fascicle length(mm), PCSA(mm^2).
Stage II: Change of contractile performance, MRI measures and clinical measures with FSHD disease progression after 1 year.
Time frame: change from baseline to 1 year follow-up
The ultrasound, MRI and clinical measures at baseline are compared with the measures after 1 year. The ultrasound Speckle-Tracking technique is employed during the dynamic approach to establish the muscle contractile performance, determined by muscle strain and displacement. The Ultrafast Shear Wave Elastography Imaging technique is used during the static approach to evaluate muscle stiffness, grey values(Z-scores) and muscle pinnation angle. For FSHD patients in this study the Medical Research Counsel scale (MRC) and/or Ricci score will be known. These measures will also be used to evaluate disease progression. The range of the MRC score is 0-5, in which '0' means no contraction of the muscle and '5' means normal contraction of the muscle. The Ricci score ranges from 0 - 10 (0= no symptoms and 10=wheelchair bound). With the MRI measurements we evaluate the muscle fat fraction (%), contractile volume(mm^3), fiber curvature, fascicle length(mm), PCSA(mm^2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: Yes. All anonymized (imaging) data will be made available in a suitable open-source online repository after the study results are published in peer-reviewed journals. A DOI will be assigned to dataset published in the Donders Data Repository (soon: Radboud Data Repository).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nens Van Alfen, MD. PhD. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscular Dystrophy, Facioscapulohumeral, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Odette Van Iersel, MSc (0243611111, Odette.vaniersel@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage I: Repeatability and feasibility of the ultrasound-defined muscle contractile performance. (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.