The study is a prospective cohort study designed to assess the diagnostic and prognostic potential of biomarker measurement in acute traumatic spinal cord injury (TSCI), and to examine the neuroinflammatory response to acute TSCI.
TSCI is an incurable condition with devastating consequences. The physical, psychosocial and financial implications in addition to a variable recovery and an uncertain prognosis have a profound impact on quality of life.The pathophysiology of TSCI is dual consisting of a primary injury and a secondary injury. The immediate trauma to the spinal cord and nerve roots causes the primary injury, while a prolonged cascade of events causes the secondary injury. The neuroinflammatory response is considered to be an important event. Current clinical measures to evaluate acute TSCI consist of clinical examination and routine imaging modalities. These measurements are inaccurate to assess injury severity, prognosis, and therapeutic efficacy, especially in the early acute phase. Biomarker measurement may provide a more accurate measure. This study aim to assess the diagnostic and prognostic potential of biomarker measurement in acute TSCI, and to examine the neuroinflammatory response to acute TSCI. To achieve this, immune cells, cytokines, autoantibodies and structural proteins will be analysed in blood and cerebrospinal fluid by Flow Cytometry and assay techniques. These analyses will be correlated to clinical outcome assessed according to international standards. Hopefully, this will contribute with new knowledge of the neuroinflammatory response and biomarkers in acute TSCI, and provide the needed knowledge for conducting futures trials in novel therapeutic interventions.
Study Type
OBSERVATIONAL
Enrollment
30
Three blood samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury. One blood sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital. Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Three cerebrospinal fluid samples will be collected from the injured participants. The assessment points are \<72 hours, 7 days and 365 days post-injury. The collected samples will be analysed by Flow Cytometry and assay techniques. One cerebrospinal fluid sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital. Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques.
Aarhus University Hospital
Aarhus, Denmark
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time frame: <72 hours, 7 days and 365 days post-injury.
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: 365 days post-injury
The Spinal Cord Independence Measure III (SCIM III)
Time frame: 365 days post-injury
Visual Analogue Pain Score (VAS)
VAS will be used to assess pain intensity. VAS is a scale ranging from 0 to 10 where "No pain" gives a score of 0 and "worst imaginable pain" gives a score of 10.
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for core
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for pain
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for bladder
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for bowel
Time frame: 365 days post-injury
International Spinal Cord Injury Dataset for sexual function
Time frame: 365 days post-injury
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical examinations will be performed at \<72 hours, 7 days and 365 days post-injury.