Clinical trial NCT02731027: Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
Official title: Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: New York State Department of Health
name: University of Louisville
name: Kessler Foundation
name: Thomas Jefferson University
name: University of British Columbia
name: Ohio State University
First posted: 2016-04-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Circulating inflammatory response from the peripheral blood for each SCI participant
timeFrame: 1 year
measure: ASIA Impairment Scale (AIS) Grade for each SCI participant
timeFrame: 1 year
Secondary outcomes:
measure: Spinal Cord Independence Measure (SCIM) for each SCI participant
timeFrame: 1 year
measure: Neuromuscular Recovery Scale (NRS) for each SCI participant
timeFrame: 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Frazier Rehab Institute, Univ. of Louisville
state: Kentucky
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research, Northwell Health
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Northwell Health System
name: Ona Bloom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: