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1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy (FSHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02159612
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):
Grete Andersen, MD, Rigshospitalet, Denmark

Brief Summary:
An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.

Condition or disease Intervention/treatment
FSHD - Facioscapulohumeral Muscular Dystrophy Other: MRI

Detailed Description:

A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan to describe the relation between backpain and disease affection in back muscles. After one year they are re-invited to perform another MRI scan to follow the disease progression.

The MRI scan is done to measure the quantity and quality of the muscles in the back, thigh and calf. Further, investigators investigate the muscle function by measuring of muscle strength in legs and in the back together with three functional tests. A walking test (6MWT), a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by a standardized questionnaire about backpain.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up
Study Start Date : May 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Group/Cohort Intervention/treatment
A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan.
Other: MRI
MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.

Primary Outcome Measures :
  1. Fat infiltration [ Time Frame: 1 year ]
    Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.

Secondary Outcome Measures :
  1. Muscle structure [ Time Frame: 1 year ]
    Muscle structure is evaluated with a four-point semi-quantitative visual scale. Two observers evaluate images independently. Changes in evaluation between 1st and 2nd scan are the outcome measure.

  2. Muscle strength [ Time Frame: 1 year ]
    Changes in muscle strength between 1st. and 2nd MRI-scan.

  3. Back pain [ Time Frame: 1 year ]
    Changes in self-assessed back-pain between 1st. and 2nd scan.

  4. Muscle function [ Time Frame: 1 year ]
    Changes in muscle function between 1st and 2nd MRI-scan, measured by a 6 minute walk test, a 14-step-stair test and a 5-times-sit-to-stand-test.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons in Denmark diagnosed with Facioscapulohumeral muscular dystrophy is invited to the study.

Inclusion Criteria:

  • Diagnosed with FSHD type 1

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Patients with claustrophobia.
  • Patients with implanted metallic parts in the body.

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 identifier (NCT number): NCT02159612

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Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Grete Andersen, MD
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Grete Andersen, MD, Medical doctor, Rigshospitalet, Denmark Identifier: NCT02159612    
Other Study ID Numbers: H-3-2012-163 (fsh)
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Keywords provided by Grete Andersen, MD, Rigshospitalet, Denmark:
Disease progression
Additional relevant MeSH terms:
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Muscular Dystrophy, Facioscapulohumeral
Muscular Dystrophies
Disease Progression
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Disease Attributes
Pathologic Processes