Multiple Sclerosis - Relapsing RemittingNCT02361697
DTI in Children With Multiple Sclerosis
A study testing DTI-MRI in people with Multiple Sclerosis - Relapsing Remitting and Clinically Isolated Syndrome, CNS Demyelinating, run by University Hospital Muenster at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis - Relapsing Remitting, Clinically Isolated Syndrome, CNS Demyelinating
- What is being tested?
- DTI-MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- claustrophobia
- allergic reaction of gadolinium (contrast medium)
- implantation of cardiac device
- implantation of neurostimulators
- implantation of cochlea implants
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Muenster
Münster, 48149
Christiane Elpers, MD, 0049 251 47774, christiane.elpers@ukmuenster.de
Gerhard Kurlemann, MD, 0049 251 47762, Gerhard.Kurlemann@ukmuenster.de
About this study
Official title: Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)
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).
Read the 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)
- Being tested
- DTI-MRI
- Keywords
- pediatric multiple sclerosis, clinically isolated syndrome in children, biomarker, magnetic resonance imaging, diffusion weighted imaging
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTI-MRIOther
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
| Study group | Role | What they receive |
|---|---|---|
| DTI-MRI | Other | MRI of the brain with specific DTI-sequences according to a specific investigation protocol Receives: Other: DTI-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
Secondary outcomes (8)
Disease activity (relapse rate, lesion load)
relapse rate, lesion load
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
- 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
Measured: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis - Relapsing RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christiane Elpers, MD, Principal investigator, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361697
- Sponsor's protocol ID
- 2014-490-f-S
- Status last verified
- May 2016
- First submitted
- 19 Jan 2015
- Last updated
- 19 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)
- ClinicalTrials.gov ID
- NCT02361697
- Acronym / sponsor ID
- 2014-490-f-S
- Keywords
- pediatric multiple sclerosis, clinically isolated syndrome in children, biomarker, magnetic resonance imaging, diffusion weighted imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DTI-MRI | Other | Other: DTI-MRIMRI of the brain with specific DTI-sequences according to a specific investigation protocol |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- pregnancy
- claustrophobia
- allergic reaction of gadolinium (contrast medium)
- implantation of cardiac device
- implantation of neurostimulators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTI-MRIMRI 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 | Other | DTI-MRI |
Primary outcome
change from baseline fractional anisotropy (FA) at 36 months 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)
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
Time frame: 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
8 secondary outcomes
Disease activity (relapse rate, lesion load)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
VEP-Score
Time frame: 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
Time frame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
Medication 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)
neurocognitive deficits neuropsychological test battery
Time frame: every 12 months (from date of randomization until the end of the study, assessed up to 36 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Elpers, MD principal investigator
University Hospital Muenster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTI-MRI in people with Multiple Sclerosis - Relapsing Remitting and Clinically Isolated Syndrome, CNS Demyelinating, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christiane Elpers, MD (0049 251 47774, christiane.elpers@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline fractional anisotropy (FA) at 36 months 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2016.