Physiologic Volume and Atrophy of Brain and Spinal Cord Measured by Magnetic Resonance Imaging
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|ClinicalTrials.gov Identifier: NCT03706118|
Recruitment Status : Active, not recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Change Atrophy Brain Atrophy; Spinal Cord Multiple Sclerosis||Other: Magnetic resonance imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, longitudinal, monocentric, interventional study|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Physiologic Interindividual Variability of Volume and Atrophy in Central Nervous System Structures With Focus on Spinal Cord as Measured by Quantitative Magnetic Resonance Imaging.|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||November 1, 2018|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: MRI and Neuropsychologic testing
102 healthy controls will be examined by magnetic resonance imaging (MRI) of brain, spinal and thoracic cord at month 0, 12, 24 and 36.
102 healthy controls will be examined by neuropsychological and walking testing designed for patients with multiple sclerosis at month 0, 12, 24 and 36.
Other: Magnetic resonance imaging
At month 0, 12, 24 and 36 participants will be examined by quantitative magnetic resonance imaging of brain, cervical and part of thoracic spine.
- Measure Spinal Cord Volume Change at 12 months during 3 years follow-up in Healthy Controls [ Time Frame: Baseline, 12, 24, 36 months ]Evaluation of Magnetic Resonance Imaging from each visit
- Measure Spinal Cord Atrophy Change at 12 months during 3 years follow-up in Healthy Controls [ Time Frame: Baseline, 12, 24, 36 months ]Evaluation of Magnetic Resonance Imaging from each visit
- Measure Whole Brain Volume and Atrophy at 12 months during 3 years follow-up in Healthy Controls [ Time Frame: Baseline, 12, 24, 36 months ]Evaluation of Magnetic Resonance Imaging from each visit
- Measure Regional Brain Volumes and Atrophies at 12 months during 3 years follow-up in Healthy Controls [ Time Frame: Baseline, 12, 24, 36 months ]Evaluation of Magnetic Resonance Imaging from each visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706118
|General University Hospital in Prague, Department of Neurology and Center of Clinical Neuroscience|
|Prague, Czechia, 12000|
|Principal Investigator:||Dana Horakova, MD, PhD||Department of Neurology and Center of Clinical Neuroscience, Charles University and General University Hospital in Prague|