DTI in Children With Multiple Sclerosis

Not Applicable

• Conditions: Clinically Isolated Syndrome, CNS Demyelinating; Multiple Sclerosis - Relapsing Remitting
• Interventions: Other: DTI-MRI

• Registration Number: NCT02361697
• Lead Sponsor: University Hospital Muenster

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)

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DTI-MRI	DTI-MRI	MRI of the brain with specific DTI-sequences according to a specific investigation protocol

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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)
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
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
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
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
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

Trial Locations

Locations (1)

University Hospital Muenster; 🇩🇪 Muenster, Germany