ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 33 for:    FSHD

Muscle Inflammation and Fat Infiltration in Patients Affected by 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.
ClinicalTrials.gov Identifier: NCT02541292
Recruitment Status : Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Julia Dahlqvist, MD, Rigshospitalet, Denmark

Brief Summary:

Facioscapulohumeral muscular dystrophy (FSHD) is the second most common muscular dystrophy with approximately 500 patients in Denmark. It is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs.

The primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with FSHD.

Approximately 15 patients with FSHD will be recruited for repeated MRI-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.


Condition or disease Intervention/treatment
Facioscapulohumeral Muscular Dystrophy 1a Other: No intervention, observational

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Muscle Inflammation and Fat Infiltration in Patients Affected by FSHD
Study Start Date : February 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


Group/Cohort Intervention/treatment
Patient group
Patients over 18 years old with confirmed FSHD (facioscapulohumeral muscular dystrophy).
Other: No intervention, observational



Primary Outcome Measures :
  1. Muscle inflammation [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]
    MRI (t2 mapping) will be used to quantify the inflammation in skeletal muscle.

  2. Muscle fat fraction [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]
    The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: One muscle strength test per subject (exam lasts approximately 60 min.) ]
    Isokinetic muscle dynamometry will be used to measure muscle strength.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Confirmed FSHD

Exclusion Criteria:

  • All contraindications for undergoing an MRI scan

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): NCT02541292


Locations
Denmark
Copenhagen Neuromuscular Center
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

Responsible Party: Julia Dahlqvist, MD, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02541292     History of Changes
Other Study ID Numbers: H-15009760
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

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