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Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT01671865
Recruitment Status : Recruiting
First Posted : August 24, 2012
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

August 21, 2012
August 24, 2012
March 3, 2017
March 2012
June 2020   (Final data collection date for primary outcome measure)
Intramuscular fat infiltration on MRI [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]
Not Provided
Complete list of historical versions of study NCT01671865 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy
Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
This study will include people with facioscapulohumeral muscular dystrophy confirmed through genetic testing.
Facioscapulohumeral Muscular Dystrophy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
June 2020
June 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to give written informed consent for study participation (a parent or guardian will be asked to provide informed consent for participants younger than 18 years old)
  • Confirmed diagnosis of FSHD through genetic testing (participants will be asked to provide copies of genetic testing results)

Exclusion Criteria:

  • Any contraindication to MRI scanning
  • Inability to complete a physical examination, including strength measurements
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact: Doris G Leung, MD, PhD 443-923-9521 leungd@kennedykrieger.org
United States
 
 
NCT01671865
NA_00065256
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Not Provided
Principal Investigator: Doris G Leung, MD, PhD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
March 2017