DTI in Children With Multiple Sclerosis

NCT ID: NCT02361697

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

DTI-MRI

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

Group Type: OTHER

DTI-MRI

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Muenster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christiane Elpers, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Muenster

Locations

University Hospital Muenster

Münster, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christiane Elpers, MD

Role: CONTACT

christiane.elpers@ukmuenster.de

0049 251 47774

Gerhard Kurlemann, MD

Role: CONTACT

Gerhard.Kurlemann@ukmuenster.de

0049 251 47762

Facility Contacts

Christiane Elpers, MD

Role: primary

christiane.elpers@ukmuenster.de

0049 251 47774

Gerhard Kurlemann, MD

Role: backup

Gerhard.Kurlemann@ukmuenster.de

0049 251 47762

Other Identifiers

2014-490-f-S

Identifier Type: -

Identifier Source: org_study_id