Clinical Trial: DTI in Children With Multiple Sclerosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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)


Sponsor: University Hospital Muenster

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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

    1. Standard Progressive Matrices (SPM)
    2. VLMT - verbal comprehension and retentivity test by Helmstaedter
    3. ROF - Rey-Osterrieth-Figure
    4. TMT A/B - Trail-Making-Test Form A and B
    5. RWT - Regensburg word fluency test
    6. block-span Corsi
    7. count span test
    8. SDMT - Symbol Digit Modalities Test
    9. BDI-II, Revision - Beck Depressions-Inventory
    10. PedsQL - Pediatric Quality of Life Inventory


Original Secondary Outcome: Same as current

Information By: University Hospital Muenster

Dates:
Date Received: January 19, 2015
Date Started: December 2014
Date Completion: December 2017
Last Updated: May 18, 2016
Last Verified: May 2016