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

Swiss Paraplegic Research, Nottwil

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Other: Healthy controls

Other: Chronic SCI patients

Other: Subacute SCI patients

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT03886610

2018-37

Details and patient eligibility

About

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.

Full 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

Enrollment

57 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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