DTI in Children With Multiple Sclerosis

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

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).

Study Overview

• Status: Unknown
• Conditions: Clinically Isolated Syndrome, CNS Demyelinating; Multiple Sclerosis - Relapsing Remitting
• Intervention / Treatment: Other: DTI-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)

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christiane Elpers, MD; Phone Number: 0049 251 47774; Email: christiane.elpers@ukmuenster.de
• Study Contact Backup: Name: Gerhard Kurlemann, MD; Phone Number: 0049 251 47762; Email: Gerhard.Kurlemann@ukmuenster.de

Study Locations

• Germany
  • Muenster, Germany, 48149
    • Recruiting
    • University Hospital Muenster
    • Contact: Christiane Elpers, MD; Phone Number: 0049 251 47774; Email: christiane.elpers@ukmuenster.de
    • Contact: Gerhard Kurlemann, MD; Phone Number: 0049 251 47762; Email: Gerhard.Kurlemann@ukmuenster.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DTI-MRI; MRI of the brain with specific DTI-sequences according to a specific investigation protocol	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity (relapse rate, lesion load)	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)	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)	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	score of visual evoked potential (amplitudes, latency) Values between 0-4	every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
SSEP somatosensory evoked potentials, records of amplitudes and latency	somatosensory evoked potentials, records of amplitudes and latency	every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
Medication particular medication of each patient	particular medication of each patient	every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
neurocognitive deficits neuropsychological test battery	neuropsychological test battery including the following tests; Standard Progressive Matrices (SPM); VLMT - verbal comprehension and retentivity test by Helmstaedter; ROF - Rey-Osterrieth-Figure; TMT A/B - Trail-Making-Test Form A and B; RWT - Regensburg word fluency test; block-span Corsi; count span test; SDMT - Symbol Digit Modalities Test; BDI-II, Revision - Beck Depressions-Inventory; PedsQL - Pediatric Quality of Life Inventory	every 12 months (from date of randomization until the end of the study, assessed up to 36 months)

Collaborators and Investigators

• Sponsor: University Hospital Muenster
• Investigators: Principal Investigator: Christiane Elpers, MD, University Hospital Muenster

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 19, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; biomarker; diffusion weighted imaging; pediatric multiple sclerosis; clinically isolated syndrome in children
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Demyelinating Diseases
• Other Study ID Numbers: 2014-490-f-S