The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

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

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injury, Acute
• Intervention / Treatment: Other: Blood samples; Other: Cerebrospinal fluid sample; Other: Clinical examination

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consist of 10 acute traumatic spinal cord injured participants admitted to the Department of Neurosurgery at Aarhus University Hospital and 20 healthy participants investigated at the Department of Neurology at Aarhus University Hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Spinal Cord Injury Centre of Western Denmark

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Inflammation; Biomarkers; Trauma; Spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 490-13-3632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No