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Muscle Oxygenation in Effort in Neuromuscular Diseases (OXYNEMU)

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ClinicalTrials.gov Identifier: NCT02789059
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

Previous studies showed modifications of muscle oxygenation parameters in muscular dystrophies du to an impairment or an absence of dystrophin.

Our study aim at assessing muscle oxygenation during effort in different neuromuscular diseases (muscular dystrophies related and not related to dystrophin, non dystrophic myopathies and motor neuron diseases) compared to a group of healthy controls. Patients and controls are invited to perform an inframaximal , standardized effort of the knee extensors by the mean of an isokinetic dynamometer. Muscle oxygenation parameters are assessed through a Near Infrared Spectroscopy (NIRS) Device.

In patients affected by dystrophin related myopathies, a muscle biopsy will be performed in order to analyse mitochondrial oxygenation parameters and mitochondrial phenotype.

Our Hypothesis is that muscle oxygenation is impaired in dystrophin related muscular dystrophies compared to other neuromuscular diseases and healthy controls because of lack of muscle capillary vessels dilatation during effort and impairment of mitochondrial function.


Condition or disease Intervention/treatment Phase
Neuromuscular Diseases Other: muscle oxygenation Not Applicable

Detailed Description:

This study is a prospective physiological study in a pathological condition (neuromuscular diseases).

5 groups of voluntary participants will be investigated:

1. 20 subjects affected by Dystrophin related muscular dystrophy (Becker Muscular Dystrophy ) 2. Subjects affected by muscular dystrophy not related to dystrophin impairment : 20 subjects affected by facioscapulohumeral dystrophy and 20 subjects affected by Limb Girdle Muscular dystrophy 3. 20 subjects affected by non-dystrophic myopathies (Congenital myopathies ) 4. 20 subjects affected by motor diseases: amyotrophic lateral sclerosis(ALS), Charcot Marie Tooth disease, Spinal Muscular Atrophy .

5. 20 healthy controls Objective: asses the muscular oxygenation modifications during a standardized effort and compare the variables between groups. Analyze the mitochondrial function and phenotype in the BMD group compared to healthy controls Outcome : Muscle Oxygenation by Near Infrared Spectroscopy parameters; oxygen consumption, Muscle Function Measure, Vignos and Brooke score, Borg scale, 6 minutes walk test, mitochondrial phenotype, mitochondrial oxygenation 3 visits : 1- inclusion 2- standardized effort protocol 3- for Becker dystrophy patients and voluntary controls, muscle biopsy of the Vastus Lateralis


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Muscle Oxygenation Modification During Effort in 4 Groups of Neuromuscular Diseases Compared to Healthy Controls, and Mitochondrial Function and Phenotype Assessment
Actual Study Start Date : July 2, 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: muscle oxygenation
assesment of muscle oxygenation and gas exchanges
Other: muscle oxygenation
Subjects will be invited to perform an isokinetic effort of the knee extensors against an isokinetic dynamometer. During this effort, muscle oxygenation and oxygen consumption will be assessed with a near infrared spectroscopy device and a gas exchange measurement device. Patients affected by Becker muscular dystrophy and healthy controls will be invited to have a muscle biopsy of the vastus lateralis.
Other Name: Muscle biopsy




Primary Outcome Measures :
  1. muscle oxygenation [ Time Frame: on the day of first evaluation Visit V1 ]
    level of deoxyhemoglobin assessed with the NIRS device during the isokinetic effort of the knee extensors

  2. Muscle oxygenation [ Time Frame: on the day of first evaluation Visit V1 ]
    kinetics of the deoxyhemoglobin assessed with the NIRS device during the isokinetic effort of the knee extensors


Secondary Outcome Measures :
  1. maximal isokinetic strength of the knee extensors [ Time Frame: on the day of first evaluation Visit V1 ]
    measurements of the maximal moment during a maximal effort of the knee extensors with an isokinetic dynamometer

  2. Gas exchange [ Time Frame: on the day of first evaluation Visit V1 ]
    measurements of O2 and CO2 exchanges during the isokinetic effort

  3. MFM score [ Time Frame: on the day of first evaluation Visit V1 ]
    Motor Function Measure score (in %) assessment. quantitative scale that makes it possible to measure the functional motor abilities of a person affected by a neuromuscular disease.

  4. 6 Minutes Walking Test (MWT) [ Time Frame: on the day of first evaluation Visit V1 ]
    assessment of the time performed during a 6 minutes walking test

  5. Vignos functional scales [ Time Frame: on the day of first evaluation Visit V1 ]
    assesment of the 1 to 6 Vignos score for the lower limb functional assesment

  6. Brooke functional scales [ Time Frame: on the day of first evaluation Visit V1 ]
    the 1 to 10 Brooke score for upper limb functional assesment

  7. Medical Research Council Muscle testing [ Time Frame: on the day of first evaluation Visit V1 ]
    Assesment of the Medical Research Council 1 to 5 Muscle testing score of the quadriceps muscles

  8. Mitochondrial phenotype [ Time Frame: at V2 at least 1 week after V1 ]
    Mitochondrial respiration (O2 consumption) of muscle fibers of the vastus lateralis

  9. Mitochondrial H2O2 production [ Time Frame: at V2 at least 1 week after V1 ]
    Mitochondrial H2O2 production of muscle fibers of the vastus lateralis

  10. kinetic of Muscle oxygenation [ Time Frame: on the day of first evaluation Visit V1 ]
    kinetic of level of deoxyhemoglobin during the isokinetic effort of the extensors of the knee



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects and
  • subjects affected by one of the fallowing neuromuscular diseases: Becker Muscular dystrophy Facioscapulohumeral dystrophy, Limb Girdle Muscular Dystrophy , Congenital Myopathy , Spinal Muscular Atrophy Charcot Marie Tooth Disease and Amyotrophic Lateral Sclerosis ,
  • able to walk
  • presenting a manual muscle testing of at Least 4/5 on the quadriceps according to the Medical research Council

Exclusion Criteria:

  • musculoskeletal pain of the quadriceps
  • other neurological disorders
  • Heart failure arrhythmia, uncontrolled hypertension, angina pectoris
  • dyspnoea >2 according to the NYHA
  • Peripheral artery disease
  • BMI >30kg.m-2.

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): NCT02789059


Contacts
Contact: Vincent Tiffreau, MD vincent.tiffereau@CHRU-LILLE.FR
Contact: Nicolas Olivier, PhD nicolas.olivier@univ-lille2.fr

Locations
France
Hôpital Amiens Nord, Service de Neurologie Not yet recruiting
Amiens, France
Contact: Philippe MERLE, MD,PhD       merle.philippe@chu-amiens.fr   
Principal Investigator: Philippe MERLE, MD,PhD         
CHRU de Lille, Hôpital Swyngedhauw Recruiting
Lille, France
Contact: Vincent TIFFEREAU, MD       vincent.tiffreau@chru-lille.fr   
Principal Investigator: Vincent TIFFREAU, MD         
Sub-Investigator: Arnaud LACOUR, MD         
Hôpital Sébastopol, CHU de Reims Not yet recruiting
Reims, France
Contact: François BOYER, MD,PhD       fboyer@chu-reims.fr   
Principal Investigator: François BOYER, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Vincent Tiffreau, MD CHRU de LILLE

Publications:
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02789059     History of Changes
Other Study ID Numbers: 2013_29
2014-A01157-40 ( Other Identifier: ID RCB number, ANSM )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
Becker muscular dystrophy
Facioscapulohumeral dystrophy
congenital myopathy
motor neurone diseases

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases