ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 33 for:    FSHD

Study of Morphology and Functional Magnetic Resonance Imaging (MRI) Muscle Patients With Muscular Dystrophy Type FSHD Benefiting a Physical Training Introduced. (FSHD3)

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: NCT01990976
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : July 28, 2015
Sponsor:
Collaborators:
Association Française contre les Myopathies (AFM), Paris
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

The safety of guided practice of physical activity in myopathies is increasingly accepted, including muscular dystrophies. In facioscapulohumeral dystrophy (FSHD), one of the most common muscular dystrophy, the aerobic training showed its physiological and functional efficiency without affecting the quality of life of patients. The issue of exercise therapy extended to all neuromuscular diseases, as has been rigorously analyzed, shows that the use of a training program combining endurance exercise targeted exercises and strength is even more relevant.

To complete the multidimensional assessments be managed by each team ( physiological assessments, functional tissue and quality of life) it is relevant to continue , for a descriptive study quantitative and qualitative analyzes by muscle imaging and spectroscopy (MRI and Nuclear Resonance Imaging (NMR) spectroscopy ).


Condition or disease Intervention/treatment
Muscular Dystrophy Facioscapulohumeral Device: MRI Procedure: Biopsy

Detailed Description:
These non-invasive assessments already in place at the time of the initial training (FSHD1 study, NCT01116570) will be repeated in the medium (12 months) and long term (30 months) in the same laboratory NMR AIM - CEA , Institute of Myology in Paris (P Carlier ). The data obtained from NMR repeated examinations and those obtained from biochemical analyzes and additional muscle histomorphometric (cellular aging estimation of involution fibroadipose ) on biopsies already programmed (initial, 6 months and 30 months, FSHD2 study, NCT01689480) will be respectively compared to initial time to follow the evolution food and energy capacity of trained muscles. The study of biopsies provide mechanistic arguments and morphometric specific cellular response to exercise, data will be advantageously complemented by NMR specialized examinations extended to all the muscles of the thigh (target of training ) and muscle quantification whole body MRI.

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Morphology and Functional Magnetic Resonance Imaging (MRI) Muscle Patients With Muscular Dystrophy Type FSHD Benefiting a Physical Training Introduced.
Study Start Date : May 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015


Group/Cohort Intervention/treatment
FSHD training
Only the patients who have participated to the FSHD1 study (NCT01116570) and the FSHD2 study (NCT01689480) can be included in this study.
Device: MRI
In Paris centre, a total body NMR imaging will be done with standard T2- and T1-weighted images.

Procedure: Biopsy
biopsy of the vastus lateralis muscle




Primary Outcome Measures :
  1. Parameters of MRI [ Time Frame: 30 months ]
    whole body imaging T1, T2-weighted


Secondary Outcome Measures :
  1. Muscle tissue parameters [ Time Frame: 30 months ]
    muscle biopsy


Biospecimen Retention:   Samples Without DNA
Muscles


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
Patient with facioscapulohumeral dystrophy and who have participated to the FSHD1 and FSHD2 studies
Criteria

Inclusion Criteria:

  • Included in the FSHD1 and FSHD2 studies
  • Social Security regimen affiliated
  • Consent form signed

Exclusion Criteria:

  • Severe cardiac or respiratory insufficiency
  • Cardiac pacemaker
  • Morbid obesity (BMI upper to 35)
  • Anti platelet therapy

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): NCT01990976


Locations
France
CHU de Grenbole
Grenoble, France, 38000
CHU de Saint-Etienne
St Etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Association Française contre les Myopathies (AFM), Paris
Ministry of Health, France
Investigators
Principal Investigator: Léonard FEASSON, MD-PhD CHU de Saint-Etienne

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01990976     History of Changes
Other Study ID Numbers: 1208050
2012-A00430-43 ( Other Identifier: AFFSAPS )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Muscular Dystrophy
Facioscapulohumeral
Physical training
Magnetic Resonance Imaging
Muscle Biopsy

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