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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTI-MRI | Other | MRI of the brain with specific DTI-sequences according to a specific investigation protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTI-MRI | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | every 6 months (from date of randomization until the end of the study, assessed up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease activity (relapse rate, lesion load) | relapse rate, lesion load | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christiane Elpers, MD | Contact | 0049 251 47774 | christiane.elpers@ukmuenster.de | |
| Gerhard Kurlemann, MD | Contact | 0049 251 47762 | Gerhard.Kurlemann@ukmuenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Christiane Elpers, MD | University Hospital Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Muenster | Recruiting | Münster | 48149 | Germany |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D003711 | Demyelinating Diseases |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 | 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) | 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 | 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 | 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 | 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
| every 12 months (from date of randomization until the end of the study, assessed up to 36 months) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D038524 |
| Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |