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Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03886610
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : March 13, 2023
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
Christiaanse Ernst, Swiss Paraplegic Centre Nottwil

Study Description
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Brief Summary:
The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome.

Condition or disease Intervention/treatment
Spinal Cord Injuries Other: Healthy controls Other: Subacute SCI patients Other: Chronic SCI patients

Detailed Description:

Injury of the spinal cord, for instance induced by trauma, is complex involving primary mechanisms caused by forces directly affecting the spinal cord and secondary mechanisms consisting of complex physiological processes after trauma.

Conventional magnetic resonance imaging (MRI) is the current standard to assess morphologic changes of the spinal cord after injury. However, conventional MRI provides little information regarding the health and integrity of the brain and spinal cord tissue itself, due to the fact that signal intensity changes are non-specific and do not correspond directly with physiological processes. This is reflected in the poor correlation of conventional MRI data with neurological and functional impairment in various spinal cord pathologies (such as multiple sclerosis compression myelopathy) and failure to provide reliable prognostic information.

By applying a combination of diffusion weighted imaging, functional MRI and magnetic resonance spectroscopy will give us a better understanding of the changes after injury of the cervical spinal cord, brainstem and brain. Correlating the imaging data with the neurological and clinical status of patients could improve the patient status prediction and therapy planning.

This study is divided into three sub-projects:

i) Reproducibility study of the MR measurements in healthy controls ii) Progression of MR biomarkers in subacute patients with SCI and comparison to chronic patients with SCI iii) Prediction of clinical outcome based on MR biomarkers

Study Design
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Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome
Actual Study Start Date : March 27, 2019
Actual Primary Completion Date : December 31, 2022
Actual Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy controls
Individuals without spinal cord injury
 Other: Healthy controls
individuals without spinal cord injury
Subacute SCI patients
Subacute patients with spinal cord injury (duration >2 weeks)
 Other: Subacute SCI patients
individuals with spinal cord injury ≥ 2 weeks
Chronic SCI patients
Patients with chronic spinal cord injury (duration ≥24 months)
 Other: Chronic SCI patients
individuals with spinal cord injury ≥ 24 months


Outcome Measures
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Primary Outcome Measures :
  1. Change in Fractional Anisotropy (FA) [ Time Frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury ]
    Degree of anisotropy of a diffusion process (value between zero and one). A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter.


Secondary Outcome Measures :
  1. Change in Apparent Diffusion Coefficient (ADC) [ Time Frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury ]
    Measurement of the magnitude of diffusion (of water molecules) within tissue

  2. Change in Relative Anisotropy (RA) [ Time Frame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury ]
    Measurement of the relative diffusion (of water molecules) within tissue


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • 20 healthy controls
  • 35 patients with subacute spinal cord injury
  • 20 patients with chronic spinal injury
Criteria

Healthy controls:

Inclusion Criteria:

  • age between 18 and 80 years
  • no previous history of severe cervical trauma, traumatic brain injury, cervical surgery or signs of neurological impairment and no known neurological disease.

Exclusion Criteria:

  • not meeting the MRI screening requirements
  • unable to give consent
  • unable to fulfill the above mentioned inclusion criteria

Subacute and chronic patients with spinal cord injury:

Inclusion Criteria:

  • lesion level at or below C3
  • etiology of the spinal cord injury is traumatic or non-traumatic
  • age between 18 and 80 years
  • time of trauma or onset of symptoms for subacute SCI patients is more than 3 weeks and for the chronic SCI patients more than 2 years

Exclusion Criteria:

  • lesion level below L2
  • other known pathology of the spinal cord/brain (e.g. MS) or progressive neurological disorders
  • inability to meet the MRI screening requirements (e.g. pacemaker or other electronic devices),
  • severe head trauma as defined by a Glasgow Coma Scale (GCS) of < 14
  • patients who are ventilator dependant
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03886610


Locations
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Switzerland
Swiss Paraplegic Centre
Nottwil, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
UMC Utrecht
Investigators
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Principal Investigator: Ernst Christiaanse, MD Swiss Paraplegic Centre
More Information
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Responsible Party: Christiaanse Ernst, Radiologist, Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03886610    
Other Study ID Numbers: 2018-37
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
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
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System