An interventional study of DTI-MRI in Multiple Sclerosis - Relapsing Remitting and Clinically Isolated Syndrome, CNS Demyelinating, sponsored by University Hospital Muenster. Status unknown at 1 site in Germany. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-19.
Sponsored by University Hospital Muenster · Not applicable, Interventional, and Diagnostic
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).
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:
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)
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 15 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Time frame: 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
Time frame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
Disease activity (relapse rate, lesion load)
relapse rate, lesion load
Time frame: 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
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)
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)
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 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
Time frame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University Hospital Muenster