Skip to navigation Skip to content
Menu

Navigation

National Multiple Sclerosis Society

Sign In
In Your Area
DonateDonate
v
  • What Is MS?

    • Definition of MS
    • What Causes MS?
    • Who Gets MS?
    • Multiple Sclerosis FAQs
    • Types of MS
    • Related Conditions
  • Symptoms & Diagnosis

    • MS Symptoms
    • Diagnosing MS
    • Magnetic Resonance Imaging (MRI)
    • Cerebrospinal Fluid (CSF)
    • Possible MS
    • Clinically Isolated Syndrome (CIS)
    • Newly Diagnosed
    • Other Conditions to Rule Out
    • For Clinicians
  • Treating MS

    • Comprehensive Care
    • Find Doctors & Resources
    • Medications
    • Managing Relapses
    • Rehabilitation
    • Complementary & Alternative Medicines
    • For Clinicians
  • Resources & Support

    • Library & Education Programs
    • Find Support
    • Advanced Care Needs
    • Resources for Specific Populations
    • Find Programs & Services in Your Area
    • Calendar of Programs and Events
    • Find Doctors & Resources
  • Living Well with MS

    • Diet, Exercise & Healthy Behaviors
    • Emotional Well-Being
    • Spiritual Well-Being
    • Cognitive Health
    • Work, Home & Leisure
    • Relationships
  • Research

    • Participate in Research Studies
    • Research News & Progress
    • Research We Fund
    • For Researchers
  • Get Involved

    • Fundraising Events
    • Volunteer
    • Advocate for Change
    • Raise Awareness
    • Join the Community
    • Stay Informed
    • Corporate Support
    • Personal Stories
  • d What Is MS?
    • d Definition of MS
      • Myelin
      • Immune-Mediated Disease
    • d What Causes MS?
      • Viruses
      • Clusters
    • d Who Gets MS?
      • Pediatric MS
      • African Americans
      • Hispanics & Latinos
    • d Multiple Sclerosis FAQs
    • d Types of MS
      • Clinically Isolated Syndrome (CIS)
      • Relapsing-remitting MS (RRMS)
      • Secondary progressive MS (SPMS)
      • Primary progressive MS (PPMS)
    • d Related Conditions
      • Acute Disseminated Encephalomyelitis (ADEM)
      • Balo’s Disease
      • HTLV-I Associated Myelopathy (HAM)
      • Neuromyelitis Optica (NMO)
      • Schilder's Disease
      • Transverse Myelitis
  • d Symptoms & Diagnosis
    • d Diagnosing MS
    • d Magnetic Resonance Imaging (MRI)
    • d Cerebrospinal Fluid (CSF)
    • d Possible MS
    • d Clinically Isolated Syndrome (CIS)
    • d Newly Diagnosed
    • d Other Conditions to Rule Out
      • Lyme Disease
      • Lupus
      • Neuromyelitis Optica
      • Acute Disseminated Encephalomyelitis (ADEM)
    • d For Clinicians
  • d Treating MS
    • d Comprehensive Care
      • Developing a Healthcare Team
      • Make the Most of Your Healthcare Provider Visits
      • Advance Medical Directives
    • d Find Doctors & Resources
    • d Medications
      • Adherence
      • Patient Assistance Programs
      • Meds Used Off Label
      • Make Medications Accessible
      • Generic and Biosimilar - Medications
    • d Managing Relapses
      • Plasmapheresis
    • d Rehabilitation
      • Functional Electrical Stimulation (FES)
    • d Complementary & Alternative Medicines
      • Chiropractic Therapy
      • Marijuana
      • Massage and Bodywork
      • Acupuncture
      • Low-Dose Naltrexone
    • d For Clinicians
  • d Resources & Support
    • d Library & Education Programs
      • Webinar Series
      • Momentum Magazine
      • Educational Videos
      • Knowledge Is Power
      • Pathways to a Cure
      • Live Fully, Live Well
      • Everyday Matters
      • Free From Falls
      • Relationship Matters
      • Resilience: Addressing the Challenges of MS
      • Webcasts
      • DVDs
      • Books
      • For Kids: Keep S'myelin
      • Información en Español
      • Brochures
    • d Find Support
      • Ask an MS Navigator
      • Community at MSconnection.org
      • Join a Local Support Group
      • Peer Connections: One-on-One
      • Edward M. Dowd Personal Advocate Program
    • d Advanced Care Needs
      • Pressure Sores
      • Osteoporosis
      • Seeking Services: Questions to Ask
    • d Resources for Specific Populations
      • Pediatric MS Support
      • Veterans with Multiple Sclerosis
    • d Find Programs & Services in Your Area
    • d Calendar of Programs and Events
    • d Find Doctors & Resources
  • d Living Well with MS
    • d Diet, Exercise & Healthy Behaviors
      • Diet & Nutrition
      • Exercise
      • Heat & Temperature Sensitivity
      • Sleep
      • Vaccinations
      • Women's Health
      • Unhealthy Habits
      • Managing MS and Another Condition
      • Aging with MS
      • Anesthesia and Surgery
      • Managing Your MS
    • d Emotional Well-Being
      • Mood Changes
    • d Spiritual Well-Being
      • Building Spirituality into Your Life
    • d Cognitive Health
    • d Work, Home & Leisure
      • Employment
      • Insurance & Financial Information
      • Staying Mobile
      • Reclaiming Control
      • Accessibility
      • Technology
      • Recreation
      • Travel
      • Emergencies & Disasters
    • d Relationships
      • Disclosure
      • Family Matters
      • Parenting
      • Intimacy
      • Preventing Abuse
  • d Research
    • d Participate in Research Studies
      • Participate in a Clinical Trial
      • Surveys and Other Research Studies
      • Participate in Genetic Studies
      • Donate to Tissue Banks
    • d Research News & Progress
      • Research News
      • Stem Cells in MS
      • Progressive MS Research
      • Clinical Trials in MS
      • Wellness and Lifestyle Research
      • Diet
      • Vitamin D
      • How and Why Do Scientists Share Results
    • d Research We Fund
      • Stopping MS In Its Tracks
      • Restoring What's Been Lost
      • Ending the Disease Forever
      • How We Fund Research
      • FAQs about Society Research
      • Past Research Efforts
      • Driving Solutions
    • d For Researchers
  • d Get Involved
    • d Volunteer
      • Volunteer Information
      • Volunteer Recognition
    • d Advocate for Change
      • Become an MS Activist
      • Take Action
      • Current Advocacy Issues
      • Advocacy Results
      • Advocacy News
    • d Raise Awareness
    • d Join the Community
    • d Stay Informed
    • d Corporate Support
      • Corporate Partners
      • National Teams
      • Partnership Opportunities
    • d Personal Stories
      • Life with MS
      • Givers
      • Shakers
      • Families with MS
      • Seekers
      • Movers
      • Tributes
  • d Donate
    • d Support an Event Participant
    • d Donate Online
    • d Give in Honor or Memory
    • d Workplace Giving
    • d Employer Matching Gifts
    • d Gifts of Stock or Securities
    • d Giving Circles
      • Golden Circle
      • Circle of Distinction
      • Lawry Circle
      • Circle of Influence
    • d Planned Giving
    • d Other Ways to Give
      • Donate by Mail or Phone
  • d About the Society
    • d Vision
      • Strategic Plan
      • Independent Review of Society's Research Programs
    • d Careers
    • d Leadership
      • Board of Directors
      • Senior Leadership Team
      • Founder Sylvia Lawry
    • d Cultural Values
    • d Financials
      • Annual Reports
      • Sources of Support
    • d News
    • d Press Room
      • Events at a Glance
      • MS the Disease
      • Public Service Announcements
      • In the News Archives
    • d MS Prevalence
      • MS Prevalence FAQs
    • d Charitable Ratings
    • d Corporate Support and Programs
  • d Helpful Links
    • d Información en Español
    • d Site Map
    • d Site Tour
    • d Contact Us
  • d For Professionals
    • d Researchers
      • Society Funding
      • Deadlines
      • Apply Online
      • Funding Policies and Procedures
      • Scientific Peer Reviewers
      • Resources for Researchers
    • d Professional Resource Center
      • About MS
      • Diagnosing MS
      • Managing MS
      • Resources for You and Your Practice
      • Publications for Clinicians
      • Publications for Your Patients
      • MS Navigator Program
      • Programs and Services for Your Patients
      • Contact Us
      • Clinical Fellows
    • d Careers in MS
      • Clinical Care
      • Research
      • Have you met?
  • d Our Healthcare Voice
HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

Share this page

FacebookTwitterEmail

Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Evaluation of Muscle Oxidative Capacity Relationship With Muscular Endurance, Fatigue (Multiple Sclerosis).

Study Purpose

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. It is characterized by different progressive forms with periods of flare-ups interspersed with phases of remission. MS manifests clinically with signs of multiple neurological dysfunctions as well as less specific symptoms such as fatigue, the prevalence of which is found to be high in these patients and is independently associated with an alteration in their quality of life. Recently, a non-invasive method for assessing maximal muscle oxidative capacity (mVO2) using optical measurement of muscle oxygenation (near-infrared spectroscopy, NIRS) has been described. Measuring tissue light absorption from a skin sensor facing a muscle, makes it possible to distinguish tissue concentrations of oxyhemoglobin (HbO2) and hemoglobin (Hb). The difference in absorbance of Hb and HbO2 corresponds to the balance of O2 supply and consumption in tissue capillaries, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function. Current literature provides reference values in young healthy subjects and MS patients. This index could therefore constitute a particularly interesting non-invasive indicator of mitochondrial functioning, usable in the clinic.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with Multiple Sclerosis (MS) with a diagnosis established by MRI.
  • - Patients with a Kurtzke Expanded Disability Status Scale (EDSS) score < 5.
  • - Body mass index (BMI) < 30 Kg/m².
  • - Thickness of subcutaneous adipose tissue at the calf ≤ 20 mm.
  • - MS patients without neurological signs of flare-up since 1 month.
  • - MS patients who have not had any treatment modification during the last 2 months.
  • - Subjects affiliated to French health care system (for France).
  • - Volunteers who have given their written consent.

Exclusion Criteria:

  • - Patients suffering from progressive psychiatric pathologies (active psychosis, , etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
  • - People with poorly controlled or unstable cardiovascular disease.
  • - Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
  • - Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
  • - Pregnant or lactating women.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06083194
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Clermont-Ferrand
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Fréderic COSTES
Principal Investigator Affiliation [email protected]
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Additional Details

Following an arterial occlusion, the rate of decay of the NIRS signal is only dependent on local O2 consumption. Following an exercise increasing the oxygen consumption of the muscle (isometric contractions for 10 to 15 s), carrying out a series of brief occlusions makes it possible to calculate mVO2 (slope of O2 desaturation at each occlusion). mVO2 decreases exponentially with time, allowing calculation of a time constant (kNIRS, min-1) reflecting mitochondrial function. Furthermore, it has been shown that kNIRS correlates with mitochondrial respiration rate measured in oxygraphy (Ryan et al., 2014). A few studies have focused on the link between maximal muscular oxidative capacity (mVO2), fatigue and muscular endurance in patients with MS. Furthermore, contradictory results have been reported regarding mVO2 in this population, suggesting in one case a higher mVO2 compared to healthy subjects while others observe the opposite. This results in an imprecise assessment of maximum muscle oxidative capacity (mVO2) in MS patients and its relationship with fatigue and muscular endurance in this population. The investigator therefore propose to carry out a prospective interventional study to analyze the relationship between these different parameters. The investigator's hypothesis is the existence of a positive correlation between mVO2 and muscular endurance, and negative with fatigue. This relationship will also be sought 6 months after participants engagement in regular physical activity. Given the accumulation of functional deficits, this approach is focused on preventive medicine, and with the aim of improving the care of these patients. The statistical analyzes will be carried out with Stata software (version 15; StataCorp, College Station, Texas, USA), considering a risk of two-sided first type error of 5%. Continuous variables will be presented in the form of mean and standard deviation, according to the normality of their distribution (Shapiro-Wilk test if necessary). In case of non-normality, they will be presented in the form of median, quartiles and extreme values. Qualitative variables will be expressed in numbers and associated percentages. Graphical representations will, as much as possible, be associated with these analyses. A description of the deviations from the protocol, the patients distributed according to these deviations and the causes of abandonment will also be carried out. The number of patients included and the inclusion curve will be presented by group. Patients will be described at inclusion according to the following variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and possible treatments. The main analysis aiming to investigate the association between maximum muscle oxidative capacity (mVO2) of MS patients assessed by near-infrared spectroscopy (NIRS) and muscular endurance of the gastrocnemius muscles assessed with the unipedal plantar flexion test (Single- Leg standing Heel Raise Test (SLSHR)) will be based on a regression coefficient (Pearson or Spearman with regard to the statistical distribution), interpreted with regard to the recommendations reported in the literature. The main analysis could be supplemented by a multivariate analysis aimed at taking into account possible confounding factors (including form/type of MS, functional deficits and age); a multiple linear regression will be proposed. The normality of the residuals will be studied; if necessary, a transformation (for example logarithmic) of the dependent variable of the study may be proposed). The results will then be expressed in terms of regression coefficients and 95% confidence interval. A subgroup analysis of the main analysis will be carried out (if possible), according to age, MS, and functional deficits; which will make it possible to evaluate the robustness of the results with regard to the heterogeneity of the sample under study and the possible impact of these variables in addition to the aforementioned multivariate analysis. The maximum muscular oxidative capacity and the muscular endurance of the gastrocnemius muscles could, secondly, be treated and analyzed as categorical data with regard to the work reported in the literature; the study of their relationship will then be analyzed by the most appropriate statistical test. For the study of the relationship between two categorical variables, a chi2 test or a Fisher exact test will be confirmed by presenting the results in terms of absolute difference and 95% confidence interval. The secondary analyzes aiming to study the relationship between the maximum muscular oxidative capacity, the fatigue (FACIT-F questionnaire) and the walking capacity will be based on a regression coefficient (Pearson or Spearman with regard to the statistical distribution) and will be interpreted with regard to the recommendations reported in the literature. The variation in mVO2 at 6 months following the engagement in physical activity [assessed by the variation in energy expenditure (number of METs per week)] will be studied by the paired Student test or the Wilcoxon test; Results will be expressed in terms of effect size and 95% confidence interval.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU clermont-ferrand, Clermont-Ferrand, France

Status

Recruiting

Address

CHU clermont-ferrand

Clermont-Ferrand, , 63000

Site Contact

Lise LACLAUTRE

[email protected]

334.73.754.963

Nearest Location

Site Contact

Lise LACLAUTRE

[email protected]

334.73.754.963


Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Colophon

 

Stay Informed

Join Us

Facebook Twitter Instagram LinkedIn YouTube MS Connection
  • About the Society
    • Vision
    • Careers
    • Leadership
    • Cultural Values
    • Financials
    • News
    • Press Room
    • MS Prevalence
    • Charitable Ratings
    • Corporate Support
  • Helpful Links
    • Donate
    • MSConnection Blog
    • Información en Español
    • Glossary
    • Legal Notice/Privacy Policy
    • Site Map
    • Site Tour
    • Contact Us
  • For Professionals
    • Researchers
    • Physicians
    • Nurses
    • Rehabilitation Professionals
    • Mental Health Professionals
    • Health and Wellness Professionals
  • What Is MS?
  • Symptoms & Diagnosis
  • Treating MS
  • Resources & Support
  • Living Well with MS
  • Research
  • Get Involved
Hidden Link