Clinical Trial: Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy

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

Official Title: Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy

Brief Summary: The purpose of this research study is to identify and study changes in muscle in people with facioscapulohumeral muscular dystrophy using magnetic resonance imaging and spectroscopy.

Detailed Summary: This research study is being done to study changes in muscle imaging over time in people with facioscapulohumeral muscular dystrophy (FSHD). Whole-body magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) will be used to evaluate skeletal muscle in study participants. This research is being done to assess how changes in muscle imaging correspond to muscle strength and function. Qualified participants will be asked to complete 5 study visits over 21 months. Each visit will include muscle strength and function testing in addition to the MRI/MRS scan. The investigators plan to use MRI and MRS in developing outcome measures that can be used in future clinical trials for FSHD.
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Current Primary Outcome: Intramuscular fat infiltration on MRI [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]

Original Primary Outcome:

Current Secondary Outcome:

  • Intramuscular edema on MRI [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]
  • Muscle strength testing [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]
  • Timed function testing [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]


Original Secondary Outcome:

Information By: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Dates:
Date Received: August 21, 2012
Date Started: March 2012
Date Completion: June 2020
Last Updated: March 1, 2017
Last Verified: March 2017