Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03087136
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2017-03-15
Brief Title:
A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil
Sponsor:
Pontificia Universidade Católica do Rio Grande do Sul
Organization:
Pontificia Universidade Católica do Rio Grande do Sul
Study Overview
Official Title:
A Multicenter Observational Study to Evaluate Pediatric Multiple Sclerosis in Brazil
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMOCEMP
Brief Summary:
Pediatric Multiple sclerosis MS is a chronic inflammatory disease defined by multiple episodes of demyelination of the central nervous system CNS separated by time and space as specified in adults not explained by acute disseminated encephalomyelitis ADEM Several studies have indicated that at least 5 of MS patients are in the pediatric population but no prospective study was performed in Brazil There are particular characteristics of Pediatric MS that differs from the adult population and have been focus of interest in the last years However we still lack high evidence data specially concerning treatment of this age group
This is an observational non-interventional multicenter study in pediatric MS patients in which participating subjects will be characterized by their clinical MRI and immunological features In this observational study we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group IPMSSG criteria for MS7 especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely Following the inclusion on the study subjects will be followed for at least 2 years
All subjects enrolled in this study will have serum collected to test autoantibodies including anti-AQP4 and anti-MOG using cell-based assays with transfected cells8 Pediatric patients with positive testing for these autoantibodies will be analyzed separately
Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS we will perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a 3-Tesla MRI GE Signa HDx 30T General Electric Milwaukee WI USA and a 8-channel head coil to visualize remyelinating brain MS lesions Normalized leptokurtic diffusion NLD data will be acquired using diffusion-weighted echo planar imaging All MRI scans from this exploratory study will be performed at the Brain Institute of Rio Grande do Sul BraIns Only patients with previous brain demyelinating lesions will be included in this exploratory sub-study
This is an observational non-interventional multicenter study in pediatric MS patients in which participating subjects will be characterized by their clinical MRI and immunological features In this observational study we will select 8 MS centers in Brazil to recruit at least 100 pediatric patients currently followed on each center with idiopathic inflammatory CNS disorders over a 2-year study period We will collect retrospective and prospective clinical and MRI data to determine the proportion of patients who fulfill the International Pediatric Multiple Sclerosis Study Group IPMSSG criteria for MS7 especially on those below 10 years where the use of McDonald 2010 criteria is not recommended routinely Following the inclusion on the study subjects will be followed for at least 2 years
All subjects enrolled in this study will have serum collected to test autoantibodies including anti-AQP4 and anti-MOG using cell-based assays with transfected cells8 Pediatric patients with positive testing for these autoantibodies will be analyzed separately
Exploratory MRI sub-study In 10 patients recruited at Hospital São Lucas PUCRS we will perform an exploratory substudy with advanced MRI using q-space diffusion protocol on a 3-Tesla MRI GE Signa HDx 30T General Electric Milwaukee WI USA and a 8-channel head coil to visualize remyelinating brain MS lesions Normalized leptokurtic diffusion NLD data will be acquired using diffusion-weighted echo planar imaging All MRI scans from this exploratory study will be performed at the Brain Institute of Rio Grande do Sul BraIns Only patients with previous brain demyelinating lesions will be included in this exploratory sub-study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None