Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury (SCIMARK)

Northwell Health

Status: Completed

Conditions: Spinal Cord Injury

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02731027

14612

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

Healthy Controls

Participants with Spinal Cord Injury