Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
- Conditions
- Spinal Cord Injury
- Registration Number
- NCT02731027
- Lead Sponsor
- Northwell Health
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Circulating inflammatory response from the peripheral blood for each SCI participant 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 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 Outcome Measures
Name Time Method Neuromuscular Recovery Scale (NRS) for each SCI participant 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.
Spinal Cord Independence Measure (SCIM) for each SCI participant 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.
Trial Locations
- Locations (6)
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Frazier Rehab Institute, Univ. of Louisville
🇺🇸Louisville, Kentucky, United States
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Kessler Institute for Rehabilitation
🇺🇸West Orange, New Jersey, United States
The Feinstein Institute for Medical Research, Northwell Health
🇺🇸Manhasset, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States