The primary objective of the study is to investigate changes in white matter structural integrity in patients with relapsing remitting multiple sclerosis (MS) after treatment with dimethyl fumarate and its relation to physical and cognitive…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint that relates to the objective is change in diffusion
tensor imaging measures (fractional anisotropy and mean diffusivity).
Secondary outcome
The additional objectives and endpoints of this study in this study population
are as follows:
- Does Tecfidera limit structural brain damage over time? Endpoints: brain
atrophy, gray and white matter lesions;
- How does treatment with Tecfidera effect functional connectivity as measured
by resting-state functional MRI? Endpoint: functional connectivity changes;
- How does Tecfidera influence brain activation patterns and task performance
during an information processing speed task (task-related fMRI)? Endpoints:
improved processing speed performance, altered activation patterns;
- How does Tecfidera influence physical disability and cognitive decline?
Endpoints: change on EDSS, change on cognitive tests;
- Exploratory endpoint: How does Tecfidera influence concentrations of brain
metabolites? Endpoint: change on MR spectroscopy.
Background summary
Tecfidera (dimethyl fumarate) is a relatively new medication that can create an
optimal environment within the brain for repair by increasing the nuclear
factor erythroid 2-related factor (NRF2) which has a neuroprotective role on
neurons, oligodendrocytes and glia cells. As a result, Tecfidera is expected to
enhance functional adaptive processes, delaying disease progression and
cognitive decline. Predominantly due to the immunomodulatory feature of
Tecfidera (and slowing disease progression), but also because of its
neuroprotective properties.
Study objective
The primary objective of the study is to investigate changes in white matter
structural integrity in patients with relapsing remitting multiple sclerosis
(MS) after treatment with dimethyl fumarate and its relation to physical and
cognitive functioning.
Study design
Single center, clinical observational study.
Study burden and risks
All subjects in this study will visit the VU University Medical Center three
times. At baseline, after 6 months and after 18 months. For the patients the
visits will consist of a neurological examination (EDSS), a neuropsychological
examination and MR imaging (structural and functional). Healthy control
subjects will undergo a similar protocol, except for the neurological
examination. At home, patients will fill out several questionnaires on anxiety
and depression, fatigue, sleep disturbances and subjective cognitive
functioning.
The burden will be mainly the time-investment in the study. Risks are limited
due to the observational character of the study. However, it is possible that
coincidental findings will be shown via the MRI-scans. In case of coincidental
findings by patients the researcher will ask the radiologist to review te
scans. In case of a coincidental finding in patients, their neurologist will be
informed. In case of coincidental findings in healthy controls, their general
practitioner will be informed
De Boelelaan 1108 (O2 gebouw 13-E01)
Amsterdam 1081 HZ
NL
De Boelelaan 1108 (O2 gebouw 13-E01)
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
To be eligible to participate in this study, candidates must meet the following
eligibility criteria at baseline:1. Ability to understand the purpose and risks
of the study and provide signed and dated informed consent and authorization to
use protected health information (PHI) in accordance with national and local
subject privacy regulations;
2. All participants should be 18-65 years of age;
3. All participants need to meet the safety criteria to undergo an MRI
examination;
4. All participants should have sufficient visual acuity and motor skills to
perform the fMRI task;For the patient groups specifically:
5. Only patients with (active) RRMS will be included;
6. Patients using other drugs influencing the CNS (such as anti-depressants,
stimulants, anti-epileptica etc) should be stable on this medication using it
for at least 6 months;
Exclusion criteria
Candidates will be excluded from study entry if any of the following exclusion
criteria exist at baseline:
1. Unable or unwilling to provide informed consent.
2. Presence or history of psychiatric or neurological disease (for patients:
neurological disease other than MS) that is expected to affect outcome measures
(will be discussed with the principal investigator and neurologist);
3. Presence of contra-indications for MRI;
4. History or presence of alcohol or drug abuse;
5. Participation in other (scientific) studies using cognitive or physical
training interventionsFor the patient groups specifically:
6. Patients with disease categorized as primary progressive, secondary
progressive or progressive relapsing;
7. Patients that had a relapse and steroid treatment within the four weeks
prior to examination.
it for
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63236.029.17 |