DTI in Children With Multiple Sclerosis

NCT02361697 | Unknown

• 1 other identifier: 2014-490-f-S
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

pediatric multiple sclerosis; clinically isolated syndrome in children; biomarker; magnetic resonance imaging; diffusion weighted imaging

Outcome Measures

Primary Outcomes (2)

• change from baseline fractional anisotropy (FA) at 36 months measured by cerebral MRI and special DTI sequences

  measured by cerebral MRI and special DTI sequences

  every 6 months (from date of randomization until the end of the study, assessed up to 36 months)

• change from baseline apparent diffusion coefficient (ADC) at 36 months measured by cerebral MRI and special DTI sequences

  measured by cerebral MRI and special DTI sequences

  every 6 months (from date of randomization until the end of the study, assessed up to 36 months)

Secondary Outcomes (8)

• Disease activity (relapse rate, lesion load)

  every 6 months (from date of randomization until the end of the study after 36 months)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  every 6 months (from date of randomization until the end of the study, assessed up to 36 months)

• EDSS (Expanded disability status scale, Values between 0-10)

  every six months (from date of randomization until the end of the study, assessed up to 36 months)

• spinal lesion load measured by spinal MRI (which is performed in each participant every 12 months)

  every 12 months (from date of randomization until the end of the study, assessed up to 36 months)

• VEP-Score

  every 6 months (from date of randomization until the end of the study, assessed up to 36 months)

Study Arms (1)

DTI-MRI

OTHER

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

Other: DTI-MRI

Interventions

DTI-MRI 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

DTI-MRI

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Demyelinating Diseases

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Christiane Elpers, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane Elpers, MD

CONTACT

0049 251 47774; christiane.elpers@ukmuenster.de

Gerhard Kurlemann, MD

CONTACT

0049 251 47762; Gerhard.Kurlemann@ukmuenster.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: February 12, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: May 19, 2016

Record last verified: 2016-05

Locations

DE (1)