DTI in Children With Multiple Sclerosis

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

Status unknownNot a drug-phase studyRelapsing MSNCT02361697

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • DTI-MRI

What it measured

Main measures

  • change from baseline fractional anisotropy (FA) at 36 months 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)

    MRI lesions

  • change from baseline apparent diffusion coefficient (ADC) at 36 months 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)

    MRI lesions

Other measures (8)

  • Disease activity (relapse rate, lesion load)

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

    RelapsesMRI lesions

  • 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)

    Safety

  • 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)

    Disability progression

  • 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)

    MRI lesions

  • VEP-Score

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

    Myelin repair

  • SSEP 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)

    Myelin repair

  • Medication 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

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

    VisionThinking and memoryMood and sleepQuality of life (reported by participants)

Who could take part

Relapsing MS · 5 to 18

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

    Loading reviews and guidelines…

    History

      1. Started

        Dec 2014

      2. Main results due

        Dec 2016

      3. Finished

        Dec 2017

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