Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23313
Enrollment
55
Registered
2016-10-04
Start date
2016-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis

Interventions

None

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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) &#8804; 5.0 5. Written informed consent Control group: 1. Minimum age 18 years 2. Written informed consent

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactMerlin M. Weeda

Department of Physics and Medical Technology - PK -1 X 102

E: M.Weeda@vumc.nlT: +31 (0) 20 444 0225

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)