Accurate multiple sclerosis atrophy measurement system

Accurate multiple sclerosis atrophy measurement system - AMS2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51042

Enrollment

Registered

2021-04-21

Start date

2021-01-18

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Multiple Sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.).

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results