The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury: A Pilot Study

Conditions
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Spinal Cord Injury, Acute

Intervention / Treatment
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* Other: Blood samples
* Other: Cerebrospinal fluid sample
* Other: Clinical examination


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Injured participants<br> | Other: Blood samples<br>* 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.<br>Other: Cerebrospinal fluid sample<br>* 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.<br>Other: Clinical examination<br>* Clinical examinations will be performed at <72 hours, 7 days and 365 days post-injury.<br>|
| Healthy participants<br> | Other: Blood samples<br>* 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.<br>Other: Cerebrospinal fluid sample<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) |  | <72 hours, 7 days and 365 days post-injury. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 365 days post-injury | 
| International Spinal Cord Injury Dataset for core |  | 365 days post-injury | 
| International Spinal Cord Injury Dataset for pain |  | 365 days post-injury | 
| International Spinal Cord Injury Dataset for bladder |  | 365 days post-injury | 
| International Spinal Cord Injury Dataset for bowel |  | 365 days post-injury | 
| International Spinal Cord Injury Dataset for sexual function |  | 365 days post-injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Spinal cord injury, Biomarkers, Trauma