The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury, Acute
- Sponsor
- University of Aarhus
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Traumatic spinal cord injury (Bony level C1-L1)
- •ISNCSCI score A-C upon inclusion.
- •Age \>18-70 years.
Exclusion Criteria
- •Prior major spine surgery in the traumatised location.
- •Major co-morbidities or co-injuries.
- •Penetrating spinal cord injury.
- •\>72 hours from injury to sample collection.
Outcomes
Primary Outcomes
Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Time Frame: <72 hours, 7 days and 365 days post-injury.
Secondary Outcomes
- International Spinal Cord Injury Dataset for bowel(365 days post-injury)
- Walking Index for Spinal Cord Injury II (WISCI II)(365 days post-injury)
- The Spinal Cord Independence Measure III (SCIM III)(365 days post-injury)
- International Spinal Cord Injury Dataset for pain(365 days post-injury)
- Visual Analogue Pain Score (VAS)(365 days post-injury)
- International Spinal Cord Injury Dataset for core(365 days post-injury)
- International Spinal Cord Injury Dataset for bladder(365 days post-injury)
- International Spinal Cord Injury Dataset for sexual function(365 days post-injury)