Clinical trial NCT03886610: Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury
Official title: Quantitative and Functional Longitudinal Multimodal Imaging of the Brain and Cervical Spinal Cord in Spinal Cord Injury: Correlation With Clinical Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
Collaborators: name: UMC Utrecht
First posted: 2019-03-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 20 healthy controls
* 35 patients with subacute spinal cord injury
* 20 patients with chronic spinal injury

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

Eligibility 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

Primary outcomes:
measure: Change in Fractional Anisotropy (FA)
timeFrame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Secondary outcomes:
measure: Change in Apparent Diffusion Coefficient (ADC)
timeFrame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
measure: Change in Relative Anisotropy (RA)
timeFrame: 16-40 days after injury, 70-96 days after injury, 150- 186 days after injury
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
Study officials:
affiliation: Swiss Paraplegic Centre
name: Ernst Christiaanse, MD
role: PRINCIPAL_INVESTIGATOR
References: