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1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy (FSHD)

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ClinicalTrials.gov Identifier: NCT02159612
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Grete Andersen, MD, Rigshospitalet, Denmark

Tracking Information
First Submitted Date June 6, 2014
First Posted Date June 10, 2014
Last Update Posted Date May 14, 2015
Study Start Date May 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2014)
Fat infiltration [ Time Frame: 1 year ]
Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02159612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 6, 2014)
  • 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.
  • Muscle strength [ Time Frame: 1 year ]
    Changes in muscle strength between 1st. and 2nd MRI-scan.
  • Back pain [ Time Frame: 1 year ]
    Changes in self-assessed back-pain between 1st. and 2nd scan.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy
Official Title Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Persons in Denmark diagnosed with Facioscapulohumeral muscular dystrophy is invited to the study.
Condition FSHD - Facioscapulohumeral Muscular Dystrophy
Intervention Other: MRI
MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.
Study Groups/Cohorts FSHD
A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan.
Intervention: Other: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 13, 2015)
45
Original Estimated Enrollment
 (submitted: June 6, 2014)
50
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosed with FSHD type 1

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Patients with claustrophobia.
  • Patients with implanted metallic parts in the body.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02159612
Other Study ID Numbers H-3-2012-163 (fsh)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Grete Andersen, MD, Rigshospitalet, Denmark
Study Sponsor Grete Andersen, MD
Collaborators Not Provided
Investigators Not Provided
PRS Account Rigshospitalet, Denmark
Verification Date May 2015