Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
Completed
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT02731027
- Run by
- Northwell Health
- People needed
- 42
- Starts
- 2015-10-01
- Expected to finish
- 2020-09-01
- Last updated by the study team
- 2020-11-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Frazier Rehab Institute, Univ. of Louisville — Louisville, Kentucky, United States
- Kessler Institute for Rehabilitation — West Orange, New Jersey, United States
- The Feinstein Institute for Medical Research, Northwell Health — Manhasset, New York, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- University of British Columbia — Vancouver, British Columbia, Canada
Full record on ClinicalTrials.gov
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