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Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02731027
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
United States Department of Defense
New York State Department of Health
University of Louisville
Kessler Foundation
Thomas Jefferson University
University of British Columbia
Information provided by (Responsible Party):
Ona Bloom, Northwell Health

March 17, 2016
April 7, 2016
July 31, 2018
October 2015
September 2019   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT02731027 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The investigators will conduct an observational, prospective, longitudinal, multi-site study of traumatic SCI patients within 0-3 days of the initial injury and throughout the first year post SCI.
Spinal Cord Injury
Not Provided
  • Healthy Controls
  • Participants with Spinal Cord Injury
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
September 2019
September 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Ona Bloom, Ph.D. 516-562-3839 obloom@northwell.edu
Contact: Ashley Chory 516-562-1331 achory@northwell.edu
Canada,   United States
 
 
NCT02731027
14612
No
Not Provided
Plan to Share IPD: No
Ona Bloom, Northwell Health
Northwell Health
  • United States Department of Defense
  • New York State Department of Health
  • University of Louisville
  • Kessler Foundation
  • Thomas Jefferson University
  • University of British Columbia
Principal Investigator: Ona Bloom, Ph.D. Northwell Health System
Northwell Health
July 2018