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Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02731027
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Spinal Cord Injury

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.

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
Study Start Date : October 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Healthy Controls
Participants with Spinal Cord Injury

Outcome Measures

Primary Outcome Measures :
  1. Circulating inflammatory response from the peripheral blood for each SCI participant [ Time Frame: 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.

  2. ASIA Impairment Scale (AIS) Grade for each SCI participant [ Time Frame: 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 :
  1. Spinal Cord Independence Measure (SCIM) for each SCI participant [ Time Frame: 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.

  2. Neuromuscular Recovery Scale (NRS) for each SCI participant [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731027

Contact: Ona Bloom, Ph.D. 516-562-3839 obloom@northwell.edu
Contact: Ashley Chory 516-562-1331 achory@northwell.edu

United States, Kentucky
Frazier Rehab Institute, Univ. of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Yukishia Austin, RN    502-582-7491    YukishiaAustin@KentuckyOneHealth.org   
Principal Investigator: Max Boakye, MD         
United States, New Jersey
Kessler Institute for Rehabilitation Not yet recruiting
West Orange, New Jersey, United States, 07052
Contact: Gail Forrest, Ph.D.    973-324-3518    gforrest@kesslerfoundation.org   
Principal Investigator: Gail Forrest, Ph.D.         
United States, New York
The Feinstein Institute for Medical Research, Northwell Health Recruiting
Manhasset, New York, United States, 11030
Contact: Ona Bloom, PhD    516-562-3839    obloom@northwell.edu   
Principal Investigator: Ona Bloom, Ph.D.         
Sponsors and Collaborators
Northwell Health
United States Department of Defense
New York State Department of Health
University of Louisville
Kessler Foundation
Principal Investigator: Ona Bloom, Ph.D. Northwell Health System
More Information

Responsible Party: Ona Bloom, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT02731027     History of Changes
Other Study ID Numbers: 14612
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System