Neuromuscular DiseasesOXYNEMUNCT02789059
Muscle Oxygenation in Effort in Neuromuscular Diseases
A study testing muscle oxygenation in people with Neuromuscular Diseases, run by University Hospital, Lille at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- muscle oxygenation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Jul 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Amiens Nord, Service de Neurologie
Amiens
CHRU de Lille, Hôpital Swyngedhauw
Lille
Hôpital Sébastopol, CHU de Reims
Reims
About this study
Official title: Muscle Oxygenation Modification During Effort in 4 Groups of Neuromuscular Diseases Compared to Healthy Controls, and Mitochondrial Function and Phenotype Assessment
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.
Read more
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.
Read the detailed description
This study is a prospective physiological study in a pathological condition (neuromuscular diseases).
5 groups of voluntary participants will be investigated:
- 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 .
- 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
- Conditions
- Neuromuscular Diseases
- Being tested
- muscle oxygenation
- Keywords
- Becker muscular dystrophy, Facioscapulohumeral dystrophy, congenital myopathy, motor neurone diseases
- Medical subject headings
- Neuromuscular Diseases, Muscular Dystrophy, Duchenne, Myotonia Congenita, Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle oxygenationOther
Also called Muscle biopsy
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.
| Study group | Role | What they receive |
|---|---|---|
| muscle oxygenation | Experimental | assesment of muscle oxygenation and gas exchanges Receives: Other: muscle oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle oxygenation
level of deoxyhemoglobin assessed with the NIRS device during the isokinetic effort of the knee extensors
Measured: on the day of first evaluation Visit V1
Muscle oxygenation
kinetics of the deoxyhemoglobin assessed with the NIRS device during the isokinetic effort of the knee extensors
Measured: on the day of first evaluation Visit V1
Secondary outcomes (10)
maximal isokinetic strength of the knee extensors
measurements of the maximal moment during a maximal effort of the knee extensors with an isokinetic dynamometer
Measured: on the day of first evaluation Visit V1
Gas exchange
measurements of O2 and CO2 exchanges during the isokinetic effort
Measured: on the day of first evaluation Visit V1
MFM score
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.
Measured: on the day of first evaluation Visit V1
6 Minutes Walking Test (MWT)
assessment of the time performed during a 6 minutes walking test
Measured: on the day of first evaluation Visit V1
Vignos functional scales
assesment of the 1 to 6 Vignos score for the lower limb functional assesment
Measured: on the day of first evaluation Visit V1
Brooke functional scales
the 1 to 10 Brooke score for upper limb functional assesment
Measured: on the day of first evaluation Visit V1
Medical Research Council Muscle testing
Assesment of the Medical Research Council 1 to 5 Muscle testing score of the quadriceps muscles
Measured: on the day of first evaluation Visit V1
Mitochondrial phenotype
Mitochondrial respiration (O2 consumption) of muscle fibers of the vastus lateralis
Measured: at V2 at least 1 week after V1
Mitochondrial H2O2 production
Mitochondrial H2O2 production of muscle fibers of the vastus lateralis
Measured: at V2 at least 1 week after V1
kinetic of Muscle oxygenation
kinetic of level of deoxyhemoglobin during the isokinetic effort of the extensors of the knee
Measured: on the day of first evaluation Visit V1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start2 Jul 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Tiffreau, MD, Principal investigator, CHRU de LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789059
- Sponsor's protocol ID
- 2013_29
- Other IDs
- 2014-A01157-40
- Acronym
- OXYNEMU
- Status last verified
- Dec 2025
- First submitted
- 24 May 2016
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 22683375Olivier N, Boissiere J, Allart E, Mucci P, Thevenon A, Daussin F, Tiffreau V. Evaluation of muscle oxygenation by near infrared spectroscopy in patients with facioscapulohumeral muscular dystrophy. Neuromuscul Disord. 2016 Jan;26(1):47-55. doi: 10.1016/j.nmd.2015.10.004. Epub 2015 Nov 11.
PubMed 26608622
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Oxygenation Modification During Effort in 4 Groups of Neuromuscular Diseases Compared to Healthy Controls, and Mitochondrial Function and Phenotype Assessment
- ClinicalTrials.gov ID
- NCT02789059
- Acronym / sponsor ID
- OXYNEMU / 2013_29
- Conditions
- Neuromuscular Diseases
- Keywords
- Becker muscular dystrophy, Facioscapulohumeral dystrophy, congenital myopathy, motor neurone diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Jul 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 .
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| muscle oxygenation | Experimental | Other: muscle oxygenationassesment of muscle oxygenation and gas exchanges |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- musculoskeletal pain of the quadriceps
- other neurological disorders
- Heart failure arrhythmia, uncontrolled hypertension, angina pectoris
- dyspnoea >2 according to the NYHA
- Peripheral artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle oxygenationAlso: Muscle biopsySubjects 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 | muscle oxygenation |
Primary outcome
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
10 secondary outcomes
maximal isokinetic strength of the knee extensors
Time frame: on the day of first evaluation Visit V1
Gas exchange
Time frame: on the day of first evaluation Visit V1
MFM score
Time frame: on the day of first evaluation Visit V1
6 Minutes Walking Test (MWT)
Time frame: on the day of first evaluation Visit V1
Vignos functional scales
Time frame: on the day of first evaluation Visit V1
Brooke functional scales
Time frame: on the day of first evaluation Visit V1
Medical Research Council Muscle testing
Time frame: on the day of first evaluation Visit V1
Mitochondrial phenotype
Time frame: at V2 at least 1 week after V1
Mitochondrial H2O2 production
Time frame: at V2 at least 1 week after V1
kinetic of Muscle oxygenation
Time frame: on the day of first evaluation Visit V1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 22683375Allart 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.
- Results publication: PubMed 26608622Olivier N, Boissiere J, Allart E, Mucci P, Thevenon A, Daussin F, Tiffreau V. Evaluation of muscle oxygenation by near infrared spectroscopy in patients with facioscapulohumeral muscular dystrophy. Neuromuscul Disord. 2016 Jan;26(1):47-55. doi: 10.1016/j.nmd.2015.10.004. Epub 2015 Nov 11.
- Individual participant dataSharing planned: Undecided
Related trials for Neuromuscular Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Tiffreau, MD principal investigator
CHRU de LILLE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle oxygenation in people with Neuromuscular Diseases, run by University Hospital, Lille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle oxygenation (time frame: on the day of first evaluation Visit V1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789059, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.