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Completed

NCT Number: NCT02159612

1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy

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.

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Key information

Conditions

FSHD - Facioscapulohumeral Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disease Progression Genetic Diseases, Inborn Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with FSHD type 1

Exclusion criteria

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

Treatment and study plan

MRI

Other

MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Grete Andersen, MD

Other

Registry information

Official study title

Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up

Acronym: FSHD

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2014
Registry last updated
May 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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