NCT02165358|Completed
Muscle MRI in Becker Muscular Dystrophy and in Limb-girdle Muscular Dystrophy Type 2I
Muscle MRI Study of Patients With Becker Muscular Dystrophy and Limb-girdle Muscular Dystrophy Type 2I
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Muscle MRI Study of Patients With Becker Muscular Dystrophy and Limb-girdle Muscular Dystrophy Type 2I
Sponsor study identifier
observational
38
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)The purpose of this study is to investigate the paradoxical muscle enlargement in the calves and tongue seen in patients affected by Becker muscular dystrophy and Limb-girdle muscular dystrophy type 2I. The enlarged calves' muscle quality will be assessed primarily on the basis of the muscle structure on MRI and based on a calculation of muscle strength per cross-sectional area.The findings will be compared with results from non-affected controls. Additionally we want to describe the tongue muscle appearance on T1-weighted MRI.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 11, 2014
Actual (reported)June 17, 2014
Actual (reported)January 2015
Actual (reported)January 2015
Actual (reported)Calves muscle quality
the investigators will describe muscle quality by: 1. MRI scans of the calves comprising of a T1-weighted MRI scan, a 3-point Dixon scan to measure the fraction of fat in the muscle, a short TI inversion recovery (STIR) scan, and a diffusion tensor imaging (DTI) scan to see the muscle fiber organization. The MRI scans will further be used to measure the fat free muscle cross-sectional area of the muscle groups responsible for plantar flexion and dorsi flexion respectively. 2. Biodex muscle strength measurements: Isokinetic muscle dynamometry measurements on plantar flexion and dorsal flexion over the ankle. 3. Calculating of muscle strength per muscle cross-sectional area
1 day
MRI T1 scan of the tongue
1 day
Patients verified with either becker muscular dystrophy or limb-girdle muscular dystrophy type 2I
Healthy controls matched for age and gender.
Danish patients genetically verified with either becker muscular dystrophy or limb-girdle muscular dystrophy type 2I
Neuromuscular Research Unit, Rigshospitalet
Copenhagen, 2100, Denmark
Nicoline Løkken, Bsc
Neuromuscular Research Unit, Rigshospitalet, Copenhagen
38 participants (actual enrollment reported by the registry).
First Submitted
June 11, 2014
First Posted
June 17, 2014
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Becker Muscular Dystrophy - A Natural History Study to Predict Efficacy of Exon Skipping
Contact the study team to confirm eligibility.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
November 11, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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