NCT02361697

DTI in Children With Multiple Sclerosis

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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)

Conditions

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

Interventions

Type	Name	Description
OTHER	DTI-MRI	MRI of the brain with special DTI-sequences are performed in each child with multiple sclerosis or clinically isolated syndrome at timepoint of first manifestation and every 6 months in a longterm follow-up of 3 years

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2015-02-12
• Last updated: 2016-05-19

Locations

1 site across 1 country: Germany