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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886610
• Other study ID #: 2018-37
• Status: Completed
• Start date: March 27, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Healthy controls
individuals without spinal cord injury
• Subacute SCI patients
individuals with spinal cord injury = 2 weeks
• Chronic SCI patients
individuals with spinal cord injury = 24 months

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil	UMC Utrecht

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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