Exploring Cortical Remyelination in Children With Multiple Sclerosis
Recruiting · NCT05258396 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
MRI without injection of contrast product
What this trial is about
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.
Who can take part
Age range
12 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed.
- Service de Neurologie Pédiatrique, Hôpital du Kremlin Bicêtre - Le Kremlin-Bicêtre, France
- CIC Neurosciences - Pitié Salpêtrière - Paris, France
- Service de Neurologie, GH Pitié Salpêtrière - Paris, France