Exploring Cortical Remyelination in Children With Multiple Sclerosis (REMYELIKIDS)

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.

Study Overview

• Status: Recruiting
• Conditions: Children With Multiple Sclerosis
• Intervention / Treatment: Other: MRI without injection of contrast product

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. 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabeth Maillart, MD, PH; Phone Number: +33 1 42 16 19 75; Email: elisabeth.maillart@aphp.fr

Study Locations

• France
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Service de Neurologie Pédiatrique, Hôpital du Kremlin Bicêtre
    • Contact: Kumaran Deiva, MD; Phone Number: +33 01 45 21 31 12; Email: kumaran.deiva@aphp.fr
  • Paris, France, 75013
    • Not yet recruiting
    • Service de Neurologie, GH Pitié Salpêtrière
    • Contact: Elisabeth Maillart, MD; Phone Number: +33 01 42 16 19 75; Email: elisabeth.maillart@aphp.fr
  • Paris, France, 75013
    • Recruiting
    • CIC Neurosciences - Pitié Salpêtrière
    • Principal Investigator: Elisabeth Maillart, MD
    • Contact: Elisabeth Maillart, MD; Phone Number: +33 01 42 16 19 75; Email: elisabeth.maillart@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with MS; Children with MS	Other: MRI without injection of contrast product; MRI without injection of contrast product
Experimental: Volunteers; matched in age and sex with patients. Volunteers will perform only one brain MRI, as requested by the neurologist	Other: MRI without injection of contrast product; MRI without injection of contrast product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
indices of cortical remyelination	To investigate the association between individual indices of cortical remyelination and neurological disability	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): September 11, 2026

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: MRI; MS
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Investigative Techniques; Chemistry Techniques, Analytical; Spectrum Analysis; Magnetic Resonance Spectroscopy
• Other Study ID Numbers: APHP210916; 2021-A02792-39 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No