Transforming Research and Clinical Knowledge in Spinal Cord Injury

NCT04565366 | Enrolling By Invitation

• 2 other identifiers: SC150198W81XWH-16-1-0497
• Study Type: observational
• Target: 726
• Locations: 1 country
• Sites: 5

Brief Summary

The overall goal of Transforming Research and Clinical Knowledge in Spinal Cord Injury (TRACK-SCI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics of acute traumatic spinal cord injury (SCI). TRACK-SCI seeks to combine high quality care variables with high density physiology data collection to better understand diagnose, characterize, and track the temporal profile of recovery for SCI patients. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-SCI site with a spinal cord injury that meets eligibility criteria.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Biomarkers; Neuroimaging; NINDS Common Data Elements; Spine Injury; Neurosurgery; Neurology

Outcome Measures

Primary Outcomes (2)

• Gene expression level in number of messenger RiboNucleic Acid (mRNA) transcripts for all genes expressed in white blood cells

  Obtained from a 4.0mL blood draw

  Baseline (healthy control group), or as close as possible to time of injury (SCI and trauma control group)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (SCI Only)

  American Spinal Injury Association standard assessment for documentation of the level and severity of a spinal cord injury (SCI). The ISNCSCI yields a grade from A to D, wherein A indicates greater severity.

  From admission to 12 months post-injury

Study Arms (3)

Spinal Cord Injury

Individuals recently admitted to hospital and diagnosed with acute, traumatic spinal cord injury.

Trauma Control

Individuals recently admitted to hospital and diagnosed with an acute, traumatic injury that is not spinal cord injury.

Healthy Control

Generally healthy individuals not recently diagnosed with an acute, traumatic injury (including spinal cord injury).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will enroll patients presenting to the Emergency Department with an acute SCI, in which the patient has sustained a traumatically induced disruption of spinal cord function, as manifested by one of the following: detection through clinical assessment of motor and/or sensory deficit from baseline, and/or radiologic evidence of cord signal disruption. For trauma controls, investigators will recruit non-neurological traumatic injury patients from the ED. For healthy controls, investigators will recruit primarily friends and family members of SCI participants.

You may qualify if:

• For SCI group: individuals at least 18 years of age recently diagnosed with acute, traumatic spinal cord injury
• For Trauma Control group: individuals at least 18 years of age recently diagnosed with acute, traumatic injury that is not spinal cord injury
• For Healthy Control group: generally healthy individuals at least 18 years of age not recently diagnosed with acute, traumatic injury (including SCI)

You may not qualify if:

• Individuals who are pregnant
• Individuals who are in-custody/prisoners
• Individuals who are under psychiatric hold
• For non-SCI individuals, they must not have had a spinal cord injury in the past
• For non-SCI individuals, they must not have a history of previous central nervous system injury (i.e. stroke, spinal cord injury, traumatic brain injury, seizures, etc.)

Sponsors & Collaborators

• University of California, San Francisco: lead
• United States Department of Defense: collaborator
• The Craig H. Neilsen Foundation: collaborator
• Wings for Life: collaborator

Study Sites (5)

University of California, San Francisco - Fresno

Fresno, California, 93721, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (5)

• Talbott JF, Whetstone WD, Readdy WJ, Ferguson AR, Bresnahan JC, Saigal R, Hawryluk GW, Beattie MS, Mabray MC, Pan JZ, Manley GT, Dhall SS. The Brain and Spinal Injury Center score: a novel, simple, and reproducible method for assessing the severity of acute cervical spinal cord injury with axial T2-weighted MRI findings. J Neurosurg Spine. 2015 Oct;23(4):495-504. doi: 10.3171/2015.1.SPINE141033. Epub 2015 Jul 10.

  PMID: 26161519 BACKGROUND

• Burke JF, Yue JK, Ngwenya LB, Winkler EA, Talbott JF, Pan JZ, Ferguson AR, Beattie MS, Bresnahan JC, Haefeli J, Whetstone WD, Suen CG, Huang MC, Manley GT, Tarapore PE, Dhall SS. Ultra-Early (<12 Hours) Surgery Correlates With Higher Rate of American Spinal Injury Association Impairment Scale Conversion After Cervical Spinal Cord Injury. Neurosurgery. 2019 Aug 1;85(2):199-203. doi: 10.1093/neuros/nyy537.

  PMID: 30496474 BACKGROUND

• Tsolinas RE, Burke JF, DiGiorgio AM, Thomas LH, Duong-Fernandez X, Harris MH, Yue JK, Winkler EA, Suen CG, Pascual LU, Ferguson AR, Huie JR, Pan JZ, Hemmerle DD, Singh V, Torres-Espin A, Omondi C, Kyritsis N, Haefeli J, Weinstein PR, de Almeida Neto CA, Kuo YH, Taggard D, Talbott JF, Whetstone WD, Manley GT, Bresnahan JC, Beattie MS, Dhall SS. Transforming Research and Clinical Knowledge in Spinal Cord Injury (TRACK-SCI): an overview of initial enrollment and demographics. Neurosurg Focus. 2020 May 1;48(5):E6. doi: 10.3171/2020.2.FOCUS191030.

  PMID: 32357323 BACKGROUND

• Dhall SS, Haefeli J, Talbott JF, Ferguson AR, Readdy WJ, Bresnahan JC, Beattie MS, Pan JZ, Manley GT, Whetstone WD. Motor Evoked Potentials Correlate With Magnetic Resonance Imaging and Early Recovery After Acute Spinal Cord Injury. Neurosurgery. 2018 Jun 1;82(6):870-876. doi: 10.1093/neuros/nyx320.

  PMID: 28973360 BACKGROUND

• McCoy DB, Dupont SM, Gros C, Cohen-Adad J, Huie RJ, Ferguson A, Duong-Fernandez X, Thomas LH, Singh V, Narvid J, Pascual L, Kyritsis N, Beattie MS, Bresnahan JC, Dhall S, Whetstone W, Talbott JF; TRACK-SCI Investigators. Convolutional Neural Network-Based Automated Segmentation of the Spinal Cord and Contusion Injury: Deep Learning Biomarker Correlates of Motor Impairment in Acute Spinal Cord Injury. AJNR Am J Neuroradiol. 2019 Apr;40(4):737-744. doi: 10.3174/ajnr.A6020. Epub 2019 Mar 28.

  PMID: 30923086 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, CSF, and white blood cells (WBCs) will be collected at the time closest to injury, Day 2, Day 3, and Day 5 if patient is in the hospital. Serum and WBCs will be collected at 6 months and 12 months post-injury. Samples will be banked at -80 degrees Celsius.

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Back Injuries

Study Officials

• Michael S Beattie, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: May 14, 2015
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Eligible datasets will become available starting 6 months after publication.
• Access Criteria: Select de-identified datasets will be made available to qualified researchers upon review and approval of a Data Collaboration Request by the TRACK-SCI Executive Committee. Eligible publicly accessible de-identified datasets will be available through ODC-SCI.

Locations

US (5)