Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— SCIMARK  

Official title:

Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731027
• Other study ID #: 14612
• Status: Completed
• Start date: October 2015
• Est. completion date: September 2020

Study information

• Verified date: November 2020
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Frazier Rehab Institute, Univ. of Louisville	Louisville	Kentucky
United States	The Feinstein Institute for Medical Research, Northwell Health	Manhasset	New York
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (8)

Lead Sponsor	Collaborator
Northwell Health	Kessler Foundation, New York State Department of Health, Ohio State University, Thomas Jefferson University, United States Department of Defense, University of British Columbia, University of Louisville

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating inflammatory response from the peripheral blood for each SCI participant	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.	1 year
Primary	ASIA Impairment Scale (AIS) Grade for each SCI participant	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.	1 year
Secondary	Spinal Cord Independence Measure (SCIM) for each SCI participant	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.	1 year
Secondary	Neuromuscular Recovery Scale (NRS) for each SCI participant	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.	1 year