Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05258396

Exploring Cortical Remyelination in Children With Multiple Sclerosis

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurologie Pédiatrique, Hôpital du Kremlin Bicêtre, Le Kremlin-Bicêtre, France

Loading trial locations.

About this study

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. The 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. 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for 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

Inclusion criteria

for Volunteers:

  • age between 12 years old and 18 years old
  • absence of any neurological
  • signature of the consent by the 2 holders of parental authority

Exclusion criteria

for both groups:

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

Treatment and study plan

MRI without injection of contrast product

Other

MRI without injection of contrast product

Primary outcomes

  1. MTR-based individual indices

    Time frame: 1 day

    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 outcomes

  1. indices of cortical remyelination

    Time frame: 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elisabeth Maillart, MD, PH

CONTACT

[email protected]

1 42 16 19 75 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: REMYELIKIDS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.