Accurate multiple sclerosis atrophy measurement system

Completed

Conditions: Multiple Sclerosis
10012303

Registration Number: NL-OMON51042

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

MS patient group:
1. Clincally definite relapsing-remitting, secondary progressive, primary
progressive MS, according to McDonald criteria (2017).
2. 18 to 70 years old.
3. Be able to undergo 6 MRI scans (scan and rescan on three different MR
scanners) in one day
4. Written informed consent

Healthy controls:
1. 18 to 70 years old.
2. Written informed consent

Exclusion Criteria

1. Inability to undergo MRI, e.g. metal objects in or around the body,
claustrophobia or inability to lie still in the
scanner.
2. Pregnant
3. Past or current clinically relevant non-MS neurological or psychiatric
disorder(s)
4. Past or current clinically relevant (auto)immune disorder(s)
5. Colleagues from the same department, people directly involved in the study
or people with relevant relations to the aforementioned people (e.g. partner,
parent, sibling or child etc.).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is to create a proof-of-concept in a clinical setting:<br /><br>by validating the standardization directly in MS patients and controls. This<br /><br>allows us to measure the quantitative measures: inter-class correlation<br /><br>coefficient for absolute agreement and reduced volume differences between<br /><br>scanners, as well as the mean absolute differences and limits of agreement of<br /><br>inter- and intra-scanner variation. We will compare the volume of gray matter,<br /><br>white matter and the whole brain. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In the same format as the primary outcome measures, we will also look at the<br /><br>volume changes in gray matter, white matter and the whole brain. This allows us<br /><br>to measure the quantitative measures: inter-class correlation coefficient for<br /><br>absolute agreement and reduced volume differences between scanners, as well as<br /><br>the mean absolute differences and limits of agreement of inter- and<br /><br>intra-scanner variation.</p><br>