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NCT01671865 Clinical Trial

Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy

Facioscapulohumeral Muscular Dystrophy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01671865
Other study ID # NA_00065256
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2012
Est. completion date June 2024

Study information
Verified date August 2023
Source Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Facioscapulohumeral Muscular Dystrophy
  • Muscular Dystrophies
  • Muscular Dystrophy, Facioscapulohumeral

Locations
Country Name City State
United States Doris Leung Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Leung DG, Carrino JA, Wagner KR, Jacobs MA. Whole-body magnetic resonance imaging evaluation of facioscapulohumeral muscular dystrophy. Muscle Nerve. 2015 Oct;52(4):512-20. doi: 10.1002/mus.24569. Epub 2015 Mar 31. — View Citation

Leung DG, Wang X, Barker PB, Carrino JA, Wagner KR. Multivoxel proton magnetic resonance spectroscopy in facioscapulohumeral muscular dystrophy. Muscle Nerve. 2018 Jun;57(6):958-963. doi: 10.1002/mus.26048. Epub 2018 Feb 14. — View Citation

Leung DG. Magnetic resonance imaging patterns of muscle involvement in genetic muscle diseases: a systematic review. J Neurol. 2017 Jul;264(7):1320-1333. doi: 10.1007/s00415-016-8350-6. Epub 2016 Nov 25. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intramuscular fat infiltration on MRI Intramuscular fat infiltration on MRI Baseline, 3 months, 9 months, 15 months, and 21 months
Secondary Intramuscular edema on MRI Intramuscular edema on MRI Baseline, 3 months, 9 months, 15 months, and 21 months
Secondary Muscle strength testing Muscle strength testing Baseline, 3 months, 9 months, 15 months, and 21 months
Secondary Timed function testing Timed function testing Baseline, 3 months, 9 months, 15 months, and 21 months
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Completed NCT00821548 - Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients N/A
Completed NCT05178706 - Effectiveness of Upper Extremity Rehabilitation in pwFSHD (Patient With Facioscapulohumeral Dystrophia)
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