DTI in Children With Multiple Sclerosis

University Hospital Muenster

Status: Unknown

Conditions: Clinically Isolated Syndrome, CNS Demyelinating; Multiple Sclerosis - Relapsing Remitting

Treatments: Other: DTI-MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02361697

2014-490-f-S

Details and patient eligibility

About

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).

Full 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)

Enrollment: 15 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• informed consent
• diagnosis of multiple sclerosis (MS) according to the McDonald criteria 2010 and the consensus recommendations of International Pediatric MS Study Group (IPMSSG) (Krupp et al 2013)
• diagnosis of CIS according to the consensus recommendation of IPMSSG (Krupp et al 2013)
• all types of medication/therapy

Exclusion criteria

• pregnancy
• claustrophobia
• allergic reaction of gadolinium (contrast medium)
• implantation of cardiac device
• implantation of neurostimulators
• implantation of cochlea implants
• presence of tattooing (over 20% of body surface)
• presence of permanent-make-up
• presence of permanent transdermal patches
• presence of special catheter systems with temperature probes which cannot be removed
• implantation of metalliferous implants or implants which could contain metal traces
• implantation of artificial heart valves
• implantation of stents or coils
• presence of metal fragments in the eyes

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

DTI-MRI

Other group

Description:

MRI of the brain with specific DTI-sequences according to a specific investigation protocol

Treatment:

Other: DTI-MRI