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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 : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Facioscapulohumeral Muscular Dystrophy

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy
Actual Study Start Date : March 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Intramuscular edema on MRI [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]
    Intramuscular edema on MRI

  2. Muscle strength testing [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]
    Muscle strength testing

  3. Timed function testing [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]
    Timed function testing


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include people with facioscapulohumeral muscular dystrophy confirmed through genetic testing.
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671865


Contacts
Contact: Doris G Leung, MD, PhD 443-923-9521 leungd@kennedykrieger.org

Locations
United States, Maryland
Doris Leung Recruiting
Baltimore, Maryland, United States, 21205
Contact: Doris G Leung, MD, PhD    443-923-9521    leungd@kennedykrieger.org   
Principal Investigator: Doris G Leung, MD, PhD         
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
Principal Investigator: Doris G Leung, MD, PhD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Kennedy Krieger Institute Center for Genetic Muscle Disorders  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

Responsible Party: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01671865     History of Changes
Other Study ID Numbers: NA_00065256
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
FSHD
magnetic resonance imaging
magnetic resonance spectroscopy

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Facioscapulohumeral
Muscular Disorders, Atrophic
Muscular Diseases
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn