Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
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|ClinicalTrials.gov Identifier: NCT02541292|
Recruitment Status : Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : September 3, 2018
Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs.
The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD.
Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.
|Condition or disease||Intervention/treatment|
|Facioscapulohumeral Muscular Dystrophy 1a||Other: No intervention, observational|
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
Patients over 18 years old with confirmed FSHD (facioscapulohumeral muscular dystrophy).
Other: No intervention, observational
- Muscle inflammation [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle.
- Muscle fat fraction [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.
- Muscle strength [ Time Frame: One muscle strength test per subject (exam lasts approximately 60 min.) ]Isokinetic muscle dynamometry will be used to measure muscle strength.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541292
|Copenhagen Neuromuscular Center|
|Copenhagen, Denmark, 2100|