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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
Sponsor:
Information provided by (Responsible Party):
Dana Horakova, General University Hospital, Prague

Brief Summary:

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

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Czechia
General University Hospital in Prague, Department of Neurology and Center of Clinical Neuroscience
Prague, Czechia, 12000
Sponsors and Collaborators
Dana Horakova
Investigators
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Principal Investigator: Dana Horakova, MD, PhD Department of Neurology and Center of Clinical Neuroscience, Charles University and General University Hospital in Prague
  Study Documents (Full-Text)

Documents provided by Dana Horakova, General University Hospital, Prague:

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Responsible Party: Dana Horakova, Principal Investigator, General University Hospital, Prague
ClinicalTrials.gov Identifier: NCT03706118     History of Changes
Other Study ID Numbers: KHL 182/2017
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dana Horakova, General University Hospital, Prague:
Multiple Sclerosis
Spinal Cord Atrophy

Additional relevant MeSH terms:
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Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Sclerosis
Multiple Sclerosis
Atrophy
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Autoimmune Diseases
Pathological Conditions, Anatomical