No registrations found.
ID
Source
Brief title
Health condition
multiple sclerosis; white matter damage; grey matter atrophy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Three measures for WM damage will be assessed, i.e. lesion volume, lesion fractional anisotropy (FA) and NAWM FA, from which a composite WM damage score will be computed. High versus low WM damage scores will then be compared to the atrophy rates in the GM, based on subcortical volume and cortical thickness measures. From this, we can compare atrophy rates of each GM structure from baseline to year 1 between the group of patients with higher damage in the WM tracts connected to that GM structure on the one hand, and the group of patients with lower damage in those WM tracts on the other.
Similar calculations will be performed between year 1 and year 2 in order to determine whether a larger increase of WM damage over the first study year is predictive of faster subsequent GM atrophy in the second year.
Secondary outcome
Next to the measures for GM and WM damage, resting state functional connectivity measurements will be used to assess whether GM and WM damage patterns effect the functional organization of the brain at rest, either prior to GM/WM damage, or following the damage patterns observed.
Furthermore, clinical parameters (see section 8.3) will be taken into account, in order to link the structural data to functionality of the brain in the RRMS patients.
Study objective
Our hypothesis is that MS grey matter pathology, and thereby disease burden and clinical outcome, can be better predicted by looking at damage in the connected white matter in early RRMS patients
Study design
Baseline (year 0), year 1 and year 2
Intervention
None
Merlin M. Weeda
De Boelelaan 1118
Amsterdam 1081 HZ
The Netherlands
T: +31 (0) 20 444 0225
E: M.Weeda@vumc.nl
Merlin M. Weeda
De Boelelaan 1118
Amsterdam 1081 HZ
The Netherlands
T: +31 (0) 20 444 0225
E: M.Weeda@vumc.nl
Inclusion criteria
Patient group:
1. Minimum age 18 years
2. Clinically definite relapsing remitting MS for < 5 years
3. Either receiving no treatment, or receiving first line treatment for at least 6 months
4. Expanded Disability Status Score (EDSS) ≤ 5.0
5. Written informed consent
Control group:
1. Minimum age 18 years
2. Written informed consent
Exclusion criteria
1. Past or current clinically relevant non-MS neurological or psychiatric disorder(s)
2. Past or current clinically relevant (auto)immune disorder(s)
3. Treatment for MS with first line therapy for less than 6 months
4. Treatment for MS with second line therapy
5. Relapse and/or steroid treatment in past 3 months
6. Pregnancy
7. MRI incompatibility, e.g. metal objects in or around the body, claustrophobia or inability to lie still in the scanner
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 |
|---|---|
| NTR-new | NL5923 |
| NTR-old | NTR6103 |
| Other | METc VUmc : 2016.314 |