Clinical trial NCT05258396: Exploring Cortical Remyelination in Children With Multiple Sclerosis
Official title: Exploring Cortical Remyelination in Children With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children With Multiple Sclerosis
Keywords: MRI
MS
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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. 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.

Eligibility criteria: 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 condition except headaches or psychosomatic syndrome
* 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

Primary outcomes:
measure: MTR-based individual indices
timeFrame: 1 day
Secondary outcomes:
measure: indices of cortical remyelination
timeFrame: 6 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Service de Neurologie Pédiatrique, Hôpital du Kremlin Bicêtre
city: Paris
country: France
facility: CIC Neurosciences - Pitié Salpêtrière
city: Paris
country: France
facility: Service de Neurologie, GH Pitié Salpêtrière
Study officials:
References: