Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury

Status:	Recruiting
Conditions:	Hospital, Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry, Other
Healthy:	No
Age Range:	18 - Any
Updated:	4/6/2019
Start Date:	October 2015
End Date:	September 2019
Contact:	Ona Bloom, Ph.D.
Email:	obloom@northwell.edu
Phone:	516-562-3839

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.

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

We found this trial at

sites

The Feinstein Institute for Medical Research, Northwell Health

Manhasset, New York 11030

Principal Investigator: Ona Bloom, Ph.D.

Phone: 516-562-3839

from

Manhasset, NY