DTI in Children With Multiple Sclerosis

Overview

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 Title of Study: “Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

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)

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • change from baseline fractional anisotropy (FA) at 36 months measured by cerebral MRI and special DTI sequences
    • Time Frame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
    • measured by cerebral MRI and special DTI sequences
  • change from baseline apparent diffusion coefficient (ADC) at 36 months measured by cerebral MRI and special DTI sequences
    • Time Frame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
    • measured by cerebral MRI and special DTI sequences

Secondary Measures

  • Disease activity (relapse rate, lesion load)
    • Time Frame: every 6 months (from date of randomization until the end of the study after 36 months)
    • relapse rate, lesion load
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 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)
    • Time Frame: every six months (from date of randomization until the end of the study, assessed up to 36 months)
    • Expanded disability status scale, Values between 0-10
  • spinal lesion load measured by spinal MRI (which is performed in each participant every 12 months)
    • Time Frame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
    • measured by spinal MRI (which is performed in each participant every 12 months)
  • VEP-Score
    • Time Frame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
    • score of visual evoked potential (amplitudes, latency) Values between 0-4
  • SSEP somatosensory evoked potentials, records of amplitudes and latency
    • Time Frame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
    • somatosensory evoked potentials, records of amplitudes and latency
  • Medication particular medication of each patient
    • Time Frame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
    • particular medication of each patient
  • neurocognitive deficits neuropsychological test battery
    • Time Frame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital Muenster
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christiane Elpers, MD, Principal Investigator, University Hospital Muenster
  • Overall Contact(s)
    • Christiane Elpers, MD, 0049 251 47774, christiane.elpers@ukmuenster.de

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