DTI in Children With Multiple Sclerosis

Clinically Isolated Syndrome, CNS Demyelinating Clinical Trial

Official title: Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)

Status Recruiting

Clinical Trial Summary

This is a prospective, non-randomised, non-blinded, single center study of children and adolescents with multiple sclerosis and clinically isolated syndrome to detect differences or early changes in diffusion-weighted imaging (DTI) by magnetic resonance imaging (MRI).

Clinical Trial Description

In children and adolescents with either multiple sclerosis or clinically isolated syndrome an MRI with special DTI-sequences of the brain is performed at timepoint of first manifestation of disease and every 6 months at 3 Tesla MRI according to a specific investigation protocol.

Besides MRI-DTI several clinical data are recorded every 6 months:

1. expanded disability status scale (EDSS)

2. disease activity/ relapse rate

3. lesion load (number of T2-lesions)

4. brain atrophy

5. visual and somatosensoric evoked potentials (VEP, SSEP)

6. neuropsychological examination

Furthermore a complete neurological examination is done every 6 months and particular medication of each patient is recorded in a specific investigator form (case report form, CRF) ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Clinically Isolated Syndrome, CNS Demyelinating
• Demyelinating Diseases
• Multiple Sclerosis
• Multiple Sclerosis - Relapsing Remitting
• Sclerosis

• NCT number: NCT02361697
• Study type: Interventional
• Source: University Hospital Muenster
• Contact: Christiane Elpers, MD
• Phone: 0049 251 47774
• Email: christiane.elpers@ukmuenster.de
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Completion date: December 2017