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Trial record 27 of 312 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03505463
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
Aarhus University Hospital
Spinal Cord Injury Centre of Western Denmark
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment
Spinal Cord Injury, Acute 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
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury: A Pilot Study
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) [ Time Frame: <72 hours, 7 days and 365 days post-injury. ]

Secondary Outcome Measures :
  1. Walking Index for Spinal Cord Injury II (WISCI II) [ Time Frame: 365 days post-injury ]
  2. The Spinal Cord Independence Measure III (SCIM III) [ Time Frame: 365 days post-injury ]
  3. Visual Analogue Pain Score (VAS) [ Time Frame: 365 days post-injury ]
    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.

  4. International Spinal Cord Injury Dataset for core [ Time Frame: 365 days post-injury ]
  5. International Spinal Cord Injury Dataset for pain [ Time Frame: 365 days post-injury ]
  6. International Spinal Cord Injury Dataset for bladder [ Time Frame: 365 days post-injury ]
  7. International Spinal Cord Injury Dataset for bowel [ Time Frame: 365 days post-injury ]
  8. International Spinal Cord Injury Dataset for sexual function [ Time Frame: 365 days post-injury ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes 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.
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.

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03505463     History of Changes
Other Study ID Numbers: 490-13-3632
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
Spinal cord injury
Biomarkers
Inflammation
Trauma

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System