Physiologic Volume and Atrophy of Brain and Spinal Cord Measured by Magnetic Resonance Imaging

NCT03706118 | Unknown

• 1 other identifier: KHL 182/2017
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Atrophy Brain; Atrophy; Spinal Cord; Multiple Sclerosis

Keywords

Multiple Sclerosis; Spinal Cord Atrophy

Outcome Measures

Primary Outcomes (2)

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

  Evaluation of Magnetic Resonance Imaging from each visit

  Baseline, 12, 24, 36 months

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

  Evaluation of Magnetic Resonance Imaging from each visit

  Baseline, 12, 24, 36 months

Secondary Outcomes (2)

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

  Baseline, 12, 24, 36 months

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

  Baseline, 12, 24, 36 months

Study Arms (1)

MRI and Neuropsychologic testing

EXPERIMENTAL

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

Interventions

Magnetic resonance imaging OTHER

At month 0, 12, 24 and 36 participants will be examined by quantitative magnetic resonance imaging of brain, cervical and part of thoracic spine.

MRI and Neuropsychologic testing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dana Horakova: lead

Study Sites (1)

Dpt of Neurology, Charles University and General University Hospital in Prague

Prague, 12000, Czechia

Location

Related Publications (1)

• Vaneckova M, Piredda GF, Andelova M, Krasensky J, Uher T, Srpova B, Havrdova EK, Vodehnalova K, Horakova D, Hilbert T, Marechal B, Fartaria MJ, Ravano V, Kober T. Periventricular gradient of T1 tissue alterations in multiple sclerosis. Neuroimage Clin. 2022;34:103009. doi: 10.1016/j.nicl.2022.103009. Epub 2022 Apr 16.

  PMID: 35561554 DERIVED

MeSH Terms

Conditions

Atrophy; Multiple Sclerosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Dana Horakova, MD, PhD

  Dpt of Neurology, Charles University and General University Hospital in Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, longitudinal, monocentric, interventional study

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: October 15, 2018
• Study Start: March 15, 2018
• Primary Completion: September 14, 2018
• Study Completion: November 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)