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NCT Number: NCT02731027

Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury

The purpose of the study is to profile biochemical responses and measure functional recovery in parallel, throughout the 1st year after spinal cord injury (SCI), within the same participants. These responses and recovery will be evaluated in samples from people who have had a spinal cord injury due to trauma (e.g. car accident or a fall) within the first year after SCI. Specifically, the investigators will test the hypothesis that a subset of inflammatory biomarkers correlate inversely with functional recovery. The investigators will use these data to build a predictive model of functional recovery after SCI that incorporates biomarkers that can be easily quantified in the clinic.

Total anticipated enrollment will be 100 participants with SCI across three different sites (Northwell Health System (NY), The Kessler Institute for Rehabilitation (NJ), University of Louisville (KY) and may enroll up to 30 participants without SCI.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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About this study

At all study visits, a member of the study team (investigator) will collect basic demographic and health information from the participant or the participant's medical record.

Study participants will have blood drawn at each study visit (approximately 2 tablespoons). The participant will be asked to partake in 4 study visits over the course of 1 year. The first visit will be within the first 0-14 days of SCI. The 2nd, 3rd, and 4th visits will be 3, 6, and 12 months after their spinal cord injury.

At study visits 2, 3 and 4, a study investigator will also perform some clinical evaluations for research purposes to test how the participant is recovering the ability to perform activities of daily living and move after spinal cord injury.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

SCI Subject Inclusion Criteria: To be eligible for prospective enrollment, participants are required to meet the following inclusion criteria:

  • ≥18 years old with traumatic SCI
  • Injury within 0-3 days post injury prior to enrollment
  • All American Spinal Injury Association (ASIA) grade classification A-D.
  • Neurological injury level C4-T10

Exclusion criteria

To be eligible for prospective enrollment, SCI subjects are required to not meet the following exclusion criteria:

  • Stage III-IV pressure ulcers
  • Cancer, chemotherapy, neutropenia
  • Pregnancy (all female trauma patients of childbearing years are given a pregnancy test on admission as part of routine admitting labs) or lactation
  • No known previous SCI
  • Autoimmune disease
  • Pre-existing neurological disease

Treatment and study plan

Primary outcomes

  1. Circulating inflammatory response from the peripheral blood for each SCI participant

    Time frame: 1 year

    Sample 1 will take place at the earliest possible time within 0-3 days post SCI. All blood products will be collected with strict adherence to universal precautions, and whenever possible, will occur concurrently with clinical blood draws. Blood samples collected from patients with documented concurrent infections such as UTI, as indicated by fever, hematuria or increased spasticity with the presence of pyuria (>25 wbc/high power field), which will raise inflammatory biomarker levels independent of SCI, will be analyzed as a subgroup.

  2. ASIA Impairment Scale (AIS) Grade for each SCI participant

    Time frame: 1 year

    The AIS grade will be the primary functional outcome measure. Data will be collected once acutely (0-3 days), and at 3, 6, and 12 months after SCI.

Secondary outcomes

  1. Spinal Cord Independence Measure (SCIM) for each SCI participant

    Time frame: 1 year

    The SCIM score will be a secondary measure to assess sensitivity to changes in ability to perform activities of daily living and facilitate a multiscale correlative analysis with biochemical variables measured. Data will be collected once at 3, 6, 12 months after SCI.

  2. Neuromuscular Recovery Scale (NRS) for each SCI participant

    Time frame: 1 year

    To assess ability to perform tasks related to mobility, standing and walking for each SCI participant. Data will be collected once at 3,6,12 months after SCI.

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Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Kessler Foundation
  • New York State Department of Health
  • Ohio State University
  • Thomas Jefferson University
  • United States Department of Defense
  • University of British Columbia
  • University of Louisville

Registry information

Acronym: SCIMARK

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2016
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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