Clinical trial NCT02361697: DTI in Children With Multiple Sclerosis
Official title: Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis - Relapsing Remitting
Clinically Isolated Syndrome, CNS Demyelinating
Keywords: pediatric multiple sclerosis
clinically isolated syndrome in children
biomarker
magnetic resonance imaging
diffusion weighted imaging
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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

Primary outcomes:
measure: change from baseline fractional anisotropy (FA) at 36 months measured by cerebral MRI and special DTI sequences
timeFrame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
measure: change from baseline apparent diffusion coefficient (ADC) at 36 months measured by cerebral MRI and special DTI sequences
timeFrame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
Secondary outcomes:
measure: Disease activity (relapse rate, lesion load)
timeFrame: every 6 months (from date of randomization until the end of the study after 36 months)
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
measure: EDSS (Expanded disability status scale, Values between 0-10)
timeFrame: every six months (from date of randomization until the end of the study, assessed up to 36 months)
measure: spinal lesion load measured by spinal MRI (which is performed in each participant every 12 months)
timeFrame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
measure: VEP-Score
timeFrame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
measure: SSEP somatosensory evoked potentials, records of amplitudes and latency
timeFrame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
measure: Medication particular medication of each patient
timeFrame: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
measure: neurocognitive deficits neuropsychological test battery
timeFrame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Christiane Elpers, MD
role: PRINCIPAL_INVESTIGATOR
References: