The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

Spinal Cord Injury, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03505463
• Other study ID #: 490-13-3632
• Status: Active, not recruiting
• Start date: May 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury, Acute
• Wounds and Injuries

Intervention

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.
• 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.
• Clinical examination
Clinical examinations will be performed at <72 hours, 7 days and 365 days post-injury.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Spinal Cord Injury Centre of Western Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)		<72 hours, 7 days and 365 days post-injury.
Secondary	Walking Index for Spinal Cord Injury II (WISCI II)		365 days post-injury
Secondary	The Spinal Cord Independence Measure III (SCIM III)		365 days post-injury
Secondary	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
Secondary	International Spinal Cord Injury Dataset for core		365 days post-injury
Secondary	International Spinal Cord Injury Dataset for pain		365 days post-injury
Secondary	International Spinal Cord Injury Dataset for bladder		365 days post-injury
Secondary	International Spinal Cord Injury Dataset for bowel		365 days post-injury
Secondary	International Spinal Cord Injury Dataset for sexual function		365 days post-injury