Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Facioscapulohumeral Muscular Dystrophy 1a Clinical Trial

Official title:

Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02541292
• Other study ID #: H-15009760
• Status: Active, not recruiting
• Start date: February 2016
• Est. completion date: November 2018

Study information

• Verified date: August 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed FSHD

Exclusion Criteria:

• All contraindications for undergoing an MRI scan

Related Conditions & MeSH terms

• Facioscapulohumeral Muscular Dystrophy 1a
• Inflammation
• Muscular Dystrophies
• Muscular Dystrophy, Facioscapulohumeral
• Myositis

Intervention

Other:
• No intervention, observational

Locations

Country	Name	City	State
Denmark	Copenhagen Neuromuscular Center	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle inflammation	MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle.	One MRI scan per subject (exam lasts approximately 60 min.)
Primary	Muscle fat fraction	The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.	One MRI scan per subject (exam lasts approximately 60 min.)
Secondary	Muscle strength	Isokinetic muscle dynamometry will be used to measure muscle strength.	One muscle strength test per subject (exam lasts approximately 60 min.)