DTI in Children With Multiple Sclerosis
Overview
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).
Full Title of Study: “Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: December 2016
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)
Interventions
- 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
Arms, Groups and Cohorts
- Other: DTI-MRI
- MRI of the brain with specific DTI-sequences according to a specific investigation protocol
Clinical Trial Outcome Measures
Primary Measures
- 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
Secondary Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 5 Years
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University Hospital Muenster
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Christiane Elpers, MD, Principal Investigator, University Hospital Muenster
- Overall Contact(s)
- Christiane Elpers, MD, 0049 251 47774, christiane.elpers@ukmuenster.de
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