DTI in Children With Multiple Sclerosis

Clinically Isolated Syndrome, CNS Demyelinating Clinical Trial

Official title:

Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02361697
• Other study ID #: 2014-490-f-S
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: May 18, 2016
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: University Hospital Muenster
• Contact: Christiane Elpers, MD
• Phone: 0049 251 47774
• Email: christiane.elpers[@]ukmuenster.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Other:
• DTI-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

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	Yes
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	every 12 months (from date of randomization until the end of the study, assessed up to 36 months)	No