Clinically Isolated Syndrome, CNS Demyelinating, Multiple Sclerosis - Relapsing Remitting
Conditions
Keywords
pediatric multiple sclerosis, clinically isolated syndrome in children, biomarker, magnetic resonance imaging, diffusion weighted imaging
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 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
OTHERDTI-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
Sponsors
University Hospital Muenster
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline fractional anisotropy (FA) at 36 months measured by cerebral MRI and special DTI sequences | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| EDSS (Expanded disability status scale, Values between 0-10) | 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) | 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 | 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 |
| Disease activity (relapse rate, lesion load) | every 6 months (from date of randomization until the end of the study after 36 months) | relapse rate, lesion load |
| Medication particular medication of each patient | 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 | 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 |
| SSEP somatosensory evoked potentials, records of amplitudes and latency | 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 |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | every 6 months (from date of randomization until the end of the study, assessed up to 36 months) | — |
Countries
Germany
Contacts
Primary ContactChristiane Elpers, MD
Backup ContactGerhard Kurlemann, MD
Outcome results
None listed