Physiologic Interindividual Variability of Volume and Atrophy in Central Nervous System Structures With Focus on Spinal Cord as Measured by Quantitative Magnetic Resonance Imaging.

Status unknownNot a drug-phase studyMS (type not specified)NCT03706118

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Magnetic resonance imaging

What it measured

Main measures

  • Measure Spinal Cord Volume Change at 12 months during 3 years follow-up in Healthy Controls

    Baseline, 12, 24, 36 months

    MRI lesionsBrain volume loss
  • Measure Spinal Cord Atrophy Change at 12 months during 3 years follow-up in Healthy Controls

    Baseline, 12, 24, 36 months

    MRI lesionsBrain volume loss

Other measures (2)

  • Measure Whole Brain Volume and Atrophy at 12 months during 3 years follow-up in Healthy Controls

    Baseline, 12, 24, 36 months

    MRI lesionsBrain volume loss
  • Measure Regional Brain Volumes and Atrophies at 12 months during 3 years follow-up in Healthy Controls

    Baseline, 12, 24, 36 months

    MRI lesionsBrain volume loss

Who could take part

MS (type not specified) · 18 to 60

Show the full criteria

Inclusion criteria

1. Each participant must provide informed consent in accordance with local regulations 2. Age 18-60 years.

Exclusion criteria

1. Not able to undergo MRI examination 2. Not able to be examined 4 times, i.e. M 0, 12, 24, 36 during the next 3 years 3. Pregnancy at the time of enrollment into the study 4. Other disease or medical condition that can influence the volume of brain or spinal cord

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Spinal cord (SC) involvement is prevalent in multiple sclerosis (MS) and contributes importantly to disease progression. To be able reliably evaluate spinal cord volume and its changes in MS patients we need to understand variability of these parameters in sex and age matched healthy controls (HC). To date, no generally available data about these parameters in HC are available. The objective of this study is to investigate age and sex matched HC by MRI to get the basic set of the data representing both cross sectional values and its longitudinal changes. The present study will also investigate different strategies how to normalize the absolute spinal cord and brain volume data, what is a relationship between spinal cord volume and brain volume and what is the best protocol to be used in a routine clinical practice.

Papers

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History

    1. Started

      Mar 2018

    2. Main results due

      Sept 2018

    3. Finished

      Nov 2021

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