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DTI in Children With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis - Relapsing Remitting, Clinically Isolated Syndrome, CNS Demyelinating

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

DTI-MRI

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis - Relapsing Remitting focused on measuring pediatric multiple sclerosis, clinically isolated syndrome in children, biomarker, magnetic resonance imaging, diffusion weighted imaging

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University Hospital MuensterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DTI-MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Disease activity (relapse rate, lesion load)

relapse rate, lesion load

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

EDSS (Expanded disability status scale, Values between 0-10)

Expanded disability status scale, Values between 0-10

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)

VEP-Score

score of visual evoked potential (amplitudes, latency) Values between 0-4

SSEP somatosensory evoked potentials, records of amplitudes and latency

somatosensory evoked potentials, records of amplitudes and latency

Medication particular medication of each patient

particular medication of each patient

neurocognitive deficits neuropsychological test battery

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

Full Information

NCT ID

NCT02361697

First Posted

January 19, 2015

Last Updated

May 18, 2016

Sponsor

University Hospital Muenster

1. Study Identification

Unique Protocol Identification Number

NCT02361697

Brief Title

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

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Muenster

4. Oversight

Data Monitoring Committee

5. Study Description

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: expanded disability status scale (EDSS) disease activity/ relapse rate lesion load (number of T2-lesions) brain atrophy visual and somatosensoric evoked potentials (VEP, SSEP) 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DTI-MRI

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

DTI-MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

change from baseline fractional anisotropy (FA) at 36 months measured by cerebral MRI and special DTI sequences

Description

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)

Title

change from baseline apparent diffusion coefficient (ADC) at 36 months measured by cerebral MRI and special DTI sequences

Description

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)

Secondary Outcome Measure Information:

Title

Disease activity (relapse rate, lesion load)

Description

relapse rate, lesion load

Time Frame

every 6 months (from date of randomization until the end of the study after 36 months)

Title

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)

Title

EDSS (Expanded disability status scale, Values between 0-10)

Description

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)

Title

spinal lesion load measured by spinal MRI (which is performed in each participant every 12 months)

Description

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)

Title

VEP-Score

Description

score of visual evoked potential (amplitudes, latency) Values between 0-4

Time Frame

every 6 months (from date of randomization until the end of the study, assessed up to 36 months)

Title

SSEP somatosensory evoked potentials, records of amplitudes and latency

Description

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)

Title

Medication particular medication of each patient

Description

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)

Title

neurocognitive deficits neuropsychological test battery

Description

Time Frame

every 12 months (from date of randomization until the end of the study, assessed up to 36 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christiane Elpers, MD

Phone

0049 251 47774

christiane.elpers@ukmuenster.de

First Name & Middle Initial & Last Name or Official Title & Degree

Gerhard Kurlemann, MD

Phone

0049 251 47762

Gerhard.Kurlemann@ukmuenster.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christiane Elpers, MD

Organizational Affiliation

University Hospital Muenster

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Muenster

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christiane Elpers, MD

Phone

0049 251 47774

christiane.elpers@ukmuenster.de

First Name & Middle Initial & Last Name & Degree

Gerhard Kurlemann, MD

Phone

0049 251 47762

Gerhard.Kurlemann@ukmuenster.de

12. IPD Sharing Statement

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DTI in Children With Multiple Sclerosis

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