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:
- expanded disability status scale (EDSS)
- disease activity/ relapse rate
- lesion load (number of T2-lesions)
- brain atrophy
- visual and somatosensoric evoked potentials (VEP, SSEP)
- 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
- 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
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