[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533543":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy individuals",null,"Healthy individuals between 18 and 70 years old.",[13,14],"Diagnostic Test: Muscle ultrasound with surface electromyography and dynamometry","Diagnostic Test: MRI scan",{"label":16,"type":10,"description":17,"interventionNames":18},"Patients with FSHD","Individuals with clinically and genetically proven FSHD type 1 or type 2.",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DIAGNOSTIC_TEST","Muscle ultrasound with surface electromyography and dynamometry","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.",[9,16],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"MRI scan","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.",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Nens Van Alfen, MD. PhD.","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Odette Van Iersel, MSc","CONTACT","0243611111","Odette.vaniersel@radboudumc.nl",{"name":40,"role":36,"phone":37,"phoneExt":10,"email":41},"Jonne Doorduin, PhD","Jonne.Doorduin@radboudumc.nl",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":10,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Radboud university medical center","RECRUITING","Nijmegen","Gelderland","Netherlands","NL",{"type":51,"coordinates":52},"Point",[53,54],5.85278,51.8425,{"lat":54,"lon":53},[57,58],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},{"name":40,"role":36,"phone":37,"phoneExt":10,"email":41},{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[62],{"name":63,"class":64},"Solve FSHD","UNKNOWN","100533543","magnetic-resonance-imaging-and-ultrasound-comparison-with-load-evaluation-100533543",false,"NCT06227182","Magnetic Resonance Imaging and Ultrasound Comparison With Load Evaluation","Ultrasound and Magnetic Resonance Imaging for Assessing Muscle Contractile Performance in FSHD - An Exploratory Study","MUSCLE+","Inclusion Criteria:\n\n* Age between 18 and 70 years.\n* Informed consent is given by the participant.\n* Ability to read and understand written and spoken instruction in Dutch.\n* Willingness and ability to understand nature and content of the study\n\nExclusion Criteria:\n\n* BMI ≥ 35\n* Other diseases that could diffusely affect muscle integrity or disturb the imaging appearance beyond that what can be extrapolated.\n* Wheelchair dependence\n* Pregnancy\n* Stage II: Any contra-indications for MRI, including:\n\n  * Claustrophobia\n  * Pacemakers and defibrillators\n  * Nerve stimulators\n  * Intracranial clips\n  * Intraorbital or intraocular metallic fragments\n  * Cochlear implants and ferromagnetic implants (e.g. implant for scoliosis)\n  * Inability to lie supine for 60 minutes\n  * Necessity of (continuous) daytime ventilation\n  * Scoliosis surgery",true,"ALL","18 Years","70 Years",{"count":78,"type":79},100,"ESTIMATED","OBSERVATIONAL","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.",[83],"Muscular Dystrophy, Facioscapulohumeral",[85,86],"Magnetic Resonance Imaging","Muscle Ultrasound","2025-01-10",{"date":89,"type":90},"2025-01-13","ACTUAL",{"date":92,"type":90},"2024-04-10",{"date":94,"type":79},"2027-01-31",{"name":5,"class":6},1]