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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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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

Motor Asymmetry in Progressive Multiple Sclerosis Patients

Study Purpose

Project Rational. A better understanding of the causes of physical disability is an important unmet need in progressive Multiple Sclerosis patients. Progressive Multiple Sclerosis patients most often present a worsening pyramidal syndrome of lower and, to a lesser extent, upper limbs (Lublin et al., 2014) suggesting a strong corticospinal tract involvement. The systematic high resolution Magnetic Resonance Imaging exploration of lesions location and severity, as well as extra-lesional tissue, on pan-medullar and encephalic motor tracts offers the opportunity to better understand the pathological mechanism associated with motor impairment. Scientific aims. This project will follow a twofold approach. First, the investigators will consider an "inter-patient" approach where independent and absolute Magnetic Resonance metrics for each limb will be related to disability. Second, the investigators will consider an "intra-patient" approach (i.e. comparing differences of Magnetic Resonance metric and of clinical score from the left and the right side in the same patient). For this purpose, progressive Multiple Sclerosis patients with asymmetric motor impairment will be studied. Confronting clinical and Magnetic Resonance Imaging metric value asymmetries indeed offers the unique opportunity to free oneself from many confounding factors such as genetics, age, duration of disease evolution, acquisition bias, etc. These two approaches will allow us to precisely study the impact of local factors such as Multiple Sclerosis lesions located on motor tracts on motor disability. Methodology. The investigators propose an observational multicenter cross-sectional and prognostic study. This study will involve two French centers (Rennes, Marseille) and will include a total of 40 progressive Multiple Sclerosis patients with an asymmetrical motor deficit. Twenty sex and age matched controls will be needed to calibrate quantitative Magnetic Resonance imaging (magnetization transfer ratio). Encephalic and pan medullar structural and quantitative Magnetic Resonance images will be acquired at inclusion and clinical follow-up examinations will be performed at inclusion and 24 months. Detailed motor evaluation "per limb" will be performed, including the motor American Society Injury. Association sub-score and upper and lower limbs muscle strength measurements using a dynamometer.

Recruitment Criteria

Accepts Healthy Volunteers

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

Yes
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 [Patient Registry]
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

1.

  • -

    Inclusion Criteria:

    1.1/ Patients: - Aged between 18 and 60 years.
  • - Primary Progressive Multiple Sclerosis or Secondary Progressive Multiple Sclerosis as defined by Mac Donald revised criteria in 2017.
  • - Expanded Disability Status Scale lower or equal to 8.0, at inclusion.
  • - asymmetric motor deficit.
The motor deficit asymmetry will be defined by a difference of 3 or more at the American Society Injury. Association motor sub-score per limb between the right lower limb and the left lower limb.
  • - No evidence of focal inflammatory activity for at least 3 years (no clinical relapse, no gadolinium enhancement on an Magnetic Resonance Imaging scan and no new T2 lesion) - Provided written informed consent according to the Institutional review board approval.
  • - Affiliated to the French healthcare system.
1.2 / Controls:
  • - Aged between 18 and 60 years, sex and age matched with patients.
  • - Provided written informed consent according to the Institutional review board approval.
  • - Affiliated to the French healthcare system.
2.
  • - Non-

    inclusion criteria:

    2.1 /Patients: - cerebellar Expanded Disability Status Scale sub score higher than pyramidal Expanded Disability Status Scale sub score.
  • - Relapse or corticosteroids in the 30 days preceding inclusion.
  • - Other neurological diseases.
  • - Lack of ability to understand the Institutional review board consent form.
  • - Magnetic Resonance contraindications.
  • - Pregnancy and breastfeeding.
  • - Major persons subject to legal protection (legal safeguards, guardianship,curatorship), persons deprived of their liberty.
2.2 / Controls:
  • - Personal history of central nervous related disease.
  • - Familial history of Multiple Sclerosis.
  • - Personal history of spinal cord injury.
  • - Personal history of spondylotic myelopathy.
  • - Magnetic Resonance Imaging contraindication.
  • - Lack of ability to understand the Institutional review board form.
  • - Major persons subject to legal protection (legal safeguards, guardianship, curatorship), persons deprived of their liberty.
  • - Pregnancy and breastfeeding.

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.

NCT04918225
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.

Rennes University Hospital
Principal Investigator

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

Anne Kerbrat, MD
Principal Investigator Affiliation CHU Rennes
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, Primary Progressive, Multiple Sclerosis, Secondary Progressive
Arms & Interventions

Arms

: Progressive Multiple Sclerosis patients

Progressive Multiple Sclerosis patients

: Healthy Volunteers

Healthy Volunteers

Interventions

Radiation: - Magnetic Resonance Imaging

Encephalic (about 30 minutes*) lesion location assessment: 3D FLAIR, 3DT1, 3DT2 (standard OFSEP protocol) lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1) tract location assessment: 30 directions diffusion imaging (standard OFSEP protocol) B0 and B1 mapping to correct for B0 and B1 inhomogeneities ● Spinal cord (about 50 minutes*) lesion location assessment: cervical and thoracic sagittal T2 TSE (0.7x0.7x2.5mm3), axial cervical MEDIC T2* (0.7x0.7x3mm3), axial thoracic T2 (0.5x0.5x3mm3) lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1, 0.7x0.7x3mm3) on the cervical cord and on the thoracic cord tract location assessment: performed from registration on atlas B0 and B1 mapping to correct for B0 and B1 inhomogeneities

Diagnostic Test: - Neurological examination

Global disability will be scored using the Expanded Disability Status Scale score

Diagnostic Test: - Multiple Sclerosis Functional Composite

Walking disability will be scored using the 25-foot timed-walked test Arm disability will be scored using the nine-hole peg test

Diagnostic Test: - Physiotherapist examination

American Society Injury. Association motor subscore for each limb The muscle strength using a dynamometer. Two muscle groups will be tested for the upper (elbow flexors and extensors) and lower limbs (hip flexors and ankle dorsiflexion). The Ashworth Scale and the Tardieu Scale to assess spasticity. 6 minutes walking test Fatigue Severity Scale MFIS : Modified Fatigue Impact Scale

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

Hôpital de la Timone, AP-HM, Marseille, France

Status

Not yet recruiting

Address

Hôpital de la Timone, AP-HM

Marseille, , 13385

Site Contact

Bertrand Audoin, MD

[email protected]

+33(0)4 91 38 59 39

CHU de Rennes - Hôpital Pontchaillou, Rennes, France

Status

Recruiting

Address

CHU de Rennes - Hôpital Pontchaillou

Rennes, , 35033

Site Contact

Anne Kerbrat, MD

[email protected]

+33(0)299287076

Resources

Clinical Trials in MS


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

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

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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.

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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.

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