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

NCT ID: NCT03886610

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-27
• Study Completion Date: 2022-12-31

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.

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

Conditions

Spinal Cord Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy controls

Individuals without spinal cord injury

Healthy controls

Intervention Type: OTHER

individuals without spinal cord injury

Subacute SCI patients

Subacute patients with spinal cord injury (duration \>2 weeks)

Subacute SCI patients

Intervention Type: OTHER

individuals with spinal cord injury ≥ 2 weeks

Chronic SCI patients

Patients with chronic spinal cord injury (duration ≥24 months)

Chronic SCI patients

Intervention Type: OTHER

individuals with spinal cord injury ≥ 24 months

Interventions

Healthy controls

individuals without spinal cord injury

Intervention Type: OTHER

Subacute SCI patients

individuals with spinal cord injury ≥ 2 weeks

Intervention Type: OTHER

Chronic SCI patients

individuals with spinal cord injury ≥ 24 months

Intervention Type: OTHER

Eligibility Criteria

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.

Subacute and chronic patients with spinal cord injury:

• 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

• not meeting the MRI screening requirements
• unable to give consent

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Christiaanse Ernst

Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ernst Christiaanse, MD

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Centre

Locations

Swiss Paraplegic Centre

Nottwil, , Switzerland

Countries

Switzerland

Other Identifiers

2018-37

Identifier Type: -

Identifier Source: org_study_id