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

Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Switzerland
  • Nottwil, Switzerland, 6207
    • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

• 20 healthy controls
• 35 patients with subacute spinal cord injury
• 20 patients with chronic spinal injury

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fractional Anisotropy (FA)	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.	16-40 days after injury, 70-96 days after injury, 150- 186 days after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Apparent Diffusion Coefficient (ADC)	Measurement of the magnitude of diffusion (of water molecules) within tissue	16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Change in Relative Anisotropy (RA)	Measurement of the relative diffusion (of water molecules) within tissue	16-40 days after injury, 70-96 days after injury, 150- 186 days after injury

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil
• Collaborators: UMC Utrecht
• Investigators: Principal Investigator: Ernst Christiaanse, MD, Swiss Paraplegic Centre

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 2018-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No