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Exploring Cortical Remyelination in Children With Multiple Sclerosis (REMYELIKIDS)

Primary Purpose

Children With Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI without injection of contrast product
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Children With Multiple Sclerosis focused on measuring MRI, MS

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients:

age between 12 years old and 18 years old RR-MS defined by 2017 McDonald criteria no relapse the last 4 weeks no methylprednisolone or prednisolone the last 4 weeks. affiliated to the social security system signature of the consent by the 2 holders of parental authority

Volunteers:

age between 12 years old and 18 years old absence of any neurological condition except headaches or psychosomatic syndrome signature of the consent by the 2 holders of parental authority

Exclusion Criteria:

both groups: Parental rejection Contre-indication of brain MRI: pace maker, tatoo of the face, claustrophobia…. Pregnancy, copper intrauterine device

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Patients with MS

    Volunteers

    Arm Description

    Children with MS

    matched in age and sex with patients. Volunteers will perform only one brain MRI, as requested by the neurologist

    Outcomes

    Primary Outcome Measures

    MTR-based individual indices
    To investigate the association between MTR-based individual indices of cortical myelin repair in children with MS and one cognitive score (Symbol Digital Modalities Test (SDMT)) at baseline

    Secondary Outcome Measures

    indices of cortical remyelination
    To investigate the association between individual indices of cortical remyelination and neurological disability

    Full Information

    First Posted
    February 17, 2022
    Last Updated
    February 17, 2022
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05258396
    Brief Title
    Exploring Cortical Remyelination in Children With Multiple Sclerosis
    Acronym
    REMYELIKIDS
    Official Title
    Exploring Cortical Remyelination in Children With Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 15, 2022 (Anticipated)
    Primary Completion Date
    May 15, 2025 (Anticipated)
    Study Completion Date
    May 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo.
    Detailed Description
    Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo. The investigator team has performed a first study to generate for the first time magnetization transfer ratio (MTR)-based maps of cortical myelin repair in 15 adult patients with MS. We found that patients with MS showed a high variability in cortical myelin repair, with variable index of cortical remyelination. Moreover, there was a significant correlation between the index of cortical remyelination and clinical scores. Even if childhood onset MS take longer to reach states of irreversible disability, severe disability will eventually occur at a young age. Moreover, pediatric MS could be responsible for cognitive disorders. It is therefore of crucial relevance to develop research programs designed to generate novel imaging techniques to measure the efficacy of remyelinating therapies. Multiple sclerosis (MS) in children, a rare disease, follows a relapsing remitting course with a shorter interval between the first 2 clinical events and higher annualized relapse rate as compared with MS in adults. Residual deficits following clinical events are less frequent. The vast majority of children and adolescents with MS are thought to have a greater potential for myelin repair than adults. However convincing data in the literature to support this hypothesis are lacking, because until now no imaging technique has been validated to measure remyelination in vivo. Our team has performed a first study to generate for the first time magnetization transfer ratio (MTR) - based maps of cortical myelin repair in 15 adult patients with MS. The investigator team found that patients with MS showed a high variability in cortical myelin repair, with variable index of cortical remyelination. Moreover, there was a significant correlation between the index of cortical remyelination and clinical scores. Even if childhood onset MS take longer to reach states of irreversible disability, severe disability will eventually occur at a young age. Moreover, pediatric MS could be responsible for cognitive disorders. It is therefore of crucial relevance to develop research programs designed to generate novel imaging techniques to measure the efficacy of remyelinating therapies. Finally, another extremely challenging issue in the care of children with MS is the difficulty of the transition between pediatric and adult care. Over last years, at the Pitié-Salpêtrière Hospital, the neurology team created a transition program called JUMP to improve medical, educational and psychosocial outcome for adolescent patients with MS .Taking part in the present study, young patients from 16 to 18 years old could have a direct access to the JUMP program, with the coordination of the dedicated nurses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Children With Multiple Sclerosis
    Keywords
    MRI, MS

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with MS
    Arm Type
    Experimental
    Arm Description
    Children with MS
    Arm Title
    Volunteers
    Arm Type
    Experimental
    Arm Description
    matched in age and sex with patients. Volunteers will perform only one brain MRI, as requested by the neurologist
    Intervention Type
    Other
    Intervention Name(s)
    MRI without injection of contrast product
    Intervention Description
    MRI without injection of contrast product
    Primary Outcome Measure Information:
    Title
    MTR-based individual indices
    Description
    To investigate the association between MTR-based individual indices of cortical myelin repair in children with MS and one cognitive score (Symbol Digital Modalities Test (SDMT)) at baseline
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    indices of cortical remyelination
    Description
    To investigate the association between individual indices of cortical remyelination and neurological disability
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients: age between 12 years old and 18 years old RR-MS defined by 2017 McDonald criteria no relapse the last 4 weeks no methylprednisolone or prednisolone the last 4 weeks. affiliated to the social security system signature of the consent by the 2 holders of parental authority Volunteers: age between 12 years old and 18 years old absence of any neurological condition except headaches or psychosomatic syndrome signature of the consent by the 2 holders of parental authority Exclusion Criteria: both groups: Parental rejection Contre-indication of brain MRI: pace maker, tatoo of the face, claustrophobia…. Pregnancy, copper intrauterine device
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elisabeth Maillart, MD, PH
    Phone
    1 42 16 19 75
    Ext
    +33
    Email
    elisabeth.maillart@aphp.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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