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Muscle Oxygenation in Effort in Neuromuscular Diseases (OXYNEMU)

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

Tracking Information
First Submitted Date  ICMJE May 24, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date May 19, 2017
Actual Study Start Date  ICMJE July 2, 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
  • 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
  • Muscle oxygenation [ Time Frame: on the day of first evaluation Visit V1 ]
    Cinetic of the desoxyhemmoglobin assessed with the NIRS device during the isokinetic effort of the knee extensors
Change History Complete list of historical versions of study NCT02789059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
  • 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
  • Gas exchange [ Time Frame: on the day of first evaluation Visit V1 ]
    measurements of O2 and CO2 exchanges during the isokinetic effort
  • 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.
  • 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
  • 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
  • Brooke functional scales [ Time Frame: on the day of first evaluation Visit V1 ]
    the 1 to 10 Brooke score for upper limb functional assesment
  • 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
  • Mitochondrial phenotype [ Time Frame: at V2 at least 1 week after V1 ]
    Mitochondrial respiration (O2 consumption) of muscle fibers of the vastus lateralis
  • Mitochondrial H2O2 production [ Time Frame: at V2 at least 1 week after V1 ]
    Mitochondrial H2O2 production of muscle fibers of the vastus lateralis
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
  • 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 isokinetiv dynamometer
  • Gas exchange [ Time Frame: on the day of first evaluation Visit V1 ]
    measurements of O2 and CO2 exchanges during the isokinetic effort
  • 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.
  • 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
  • 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
  • Brooke functional scales [ Time Frame: on the day of first evaluation Visit V1 ]
    the 1 to 10 Brooke score for upper limb functional assesment
  • 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
  • Mitochondrial phenotype [ Time Frame: at V2 at least 1 week after V1 ]
    Mitochondrial respiration (O2 consumption) of muscle fibers of the vastus lateralis
  • Mitochondrial H2O2 production [ Time Frame: at V2 at least 1 week after V1 ]
    Mitochondrial H2O2 production of muscle fibers of the vastus lateralis
  • cinetic of Muscle oxygenation [ Time Frame: on the day of first evaluation Visit V1 ]
    cinetic of level of desoxyhemmoglobin during the isokinetic effort of the extensors of the knee
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Muscle Oxygenation in Effort in Neuromuscular Diseases
Official Title  ICMJE Muscle Oxygenation Modification During Effort in 4 Groups of Neuromuscular Diseases Compared to Healthy Controls, and Mitochondrial Function and Phenotype Assessment
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neuromuscular Diseases
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: muscle oxygenation
assesment of muscle oxygenation and gas exchanges
Intervention: Other: muscle oxygenation
Publications * Allart E, Olivier N, Hovart H, Thevenon A, Tiffreau V. Evaluation of muscle oxygenation by near-infrared spectroscopy in patients with Becker muscular dystrophy. Neuromuscul Disord. 2012 Aug;22(8):720-7. doi: 10.1016/j.nmd.2012.04.011. Epub 2012 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 26, 2016)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02789059
Other Study ID Numbers  ICMJE 2013_29
2014-A01157-40 ( Other Identifier: ID RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vincent Tiffreau, MD CHRU de LILLE
PRS Account University Hospital, Lille
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP