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van CCT (UK)

van CCT (UK)

Does MS grey matter pathology progress faster in regions with more damage in connected white matter?

- candidate number25367
- NTR NumberNTR6103
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-okt-2016
- Secondary IDs2016.314 METc VUmc
- Public TitleDoes MS grey matter pathology progress faster in regions with more damage in connected white matter?
- Scientific TitleDoes MS grey matter pathology progress faster in regions with more damage in connected white matter?
- ACRONYMRate of GM atrophy in MS
- hypothesisOur 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
- Healt Condition(s) or Problem(s) studiedMultiple sclerosis (MS)
- Inclusion criteriaPatient 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-okt-2016
- planned closingdate1-apr-2020
- Target number of participants55
- InterventionsNone
- Primary outcomeThree 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 outcomeNext 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.
- TimepointsBaseline (year 0), year 1 and year 2
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Dutch MS Research Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD4-okt-2016 - 25-nov-2016

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