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Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury

NCT ID: NCT02731027

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

No interventions assigned to this group

Participants with Spinal Cord Injury

No interventions assigned to this group

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

University of Louisville

OTHER

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Ona Bloom

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ona Bloom, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Northwell Health System

Locations

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Frazier Rehab Institute, Univ. of Louisville

Louisville, Kentucky, United States

Site Status

Kessler Institute for Rehabilitation

West Orange, New Jersey, United States

Site Status

The Feinstein Institute for Medical Research, Northwell Health

Manhasset, New York, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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14612

Identifier Type: -

Identifier Source: org_study_id