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DTI in Children With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02361697
Recruitment Status : Unknown
Verified May 2016 by University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : February 12, 2015
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis - Relapsing Remitting Clinically Isolated Syndrome, CNS Demyelinating Other: DTI-MRI Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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) ]
  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361697


Contacts
Contact: Christiane Elpers, MD 0049 251 47774 christiane.elpers@ukmuenster.de
Contact: Gerhard Kurlemann, MD 0049 251 47762 Gerhard.Kurlemann@ukmuenster.de

Locations
Germany
University Hospital Muenster Recruiting
Muenster, Germany, 48149
Contact: Christiane Elpers, MD    0049 251 47774    christiane.elpers@ukmuenster.de   
Contact: Gerhard Kurlemann, MD    0049 251 47762    Gerhard.Kurlemann@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Christiane Elpers, MD University Hospital Muenster

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT02361697     History of Changes
Other Study ID Numbers: 2014-490-f-S
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

Keywords provided by University Hospital Muenster:
pediatric multiple sclerosis
clinically isolated syndrome in children
biomarker
magnetic resonance imaging
diffusion weighted imaging

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Demyelinating Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases