Clinical Trial: Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Brief Summary:

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.


Detailed Summary:
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: September 2, 2015
Date Started: February 2016
Date Completion: December 2017
Last Updated: April 10, 2017
Last Verified: April 2017