Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
SCIMARK
1 other identifier
observational
42
2 countries
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedNovember 13, 2020
November 1, 2020
4.9 years
March 17, 2016
November 11, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Circulating inflammatory response from the peripheral blood for each SCI participant
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.
1 year
ASIA Impairment Scale (AIS) Grade for each SCI participant
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.
1 year
Secondary Outcomes (2)
Spinal Cord Independence Measure (SCIM) for each SCI participant
1 year
Neuromuscular Recovery Scale (NRS) for each SCI participant
1 year
Study Arms (2)
Healthy Controls
Participants with Spinal Cord Injury
Eligibility Criteria
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.
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- United States Department of Defensecollaborator
- New York State Department of Healthcollaborator
- University of Louisvillecollaborator
- Kessler Foundationcollaborator
- Thomas Jefferson Universitycollaborator
- University of British Columbiacollaborator
- Ohio State Universitycollaborator
Study Sites (6)
Frazier Rehab Institute, Univ. of Louisville
Louisville, Kentucky, 40202, United States
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052, United States
The Feinstein Institute for Medical Research, Northwell Health
Manhasset, New York, 11030, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of British Columbia
Vancouver, British Columbia, V5Z1M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ona Bloom, Ph.D.
Northwell Health System
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2016
First Posted
April 7, 2016
Study Start
October 1, 2015
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
November 13, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share