Spinal Cord InjuriesTRACK-SCINCT04565366
Transforming Research and Clinical Knowledge in Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by University of California, San Francisco at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 726 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 May 2015to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Ohio State University
Columbus, Ohio, 43210
University of California, San Francisco - Fresno
Fresno, California, 93721
University of Utah
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98104
About this study
Official title: Early Critical Care Decisions and Outcomes After SCI: TRACK-SCI
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.
Read the detailed description
Spinal cord injury (SCI) is a major cause of morbidity worldwide with debilitating impacts on quality of life and the healthcare system. To date, a data-dense research registry specific to SCI remains to be constructed. To this end, the study will collect SCI data across five primary domains: 1) demographics and baseline history, 2) clinical course variables from the emergency department (ED) to the intensive care unit (ICU), 3) standard of care neuroimaging (CT and MRI) and intraoperative neuromonitoring, 4) blood and cerebrospinal fluid (CSF) samples for proteomic and genetic biomarkers, and 5) outcome measures of functional disability, mental health and quality of life at 3, 6, and 12 months. The investigators seek to correlate these high-density physiology data with baseline risk factors, imaging parameters, and biomarkers for a comprehensive approach to SCI diagnosis during acute care as well as prognosis across subacute and chronic phases of recovery -- in order to truly step toward the advancement of research and clinical knowledge in SCI.
The main objective is to provide a comprehensive prospective analysis of multiple variables in acute SCI that impact long-term outcomes. This is intended to provide a rich resource for asking key questions related to the optimization of treatment, and the planning and execution of pivotal clinical trials in SCI.
Core Hypotheses:
- Multiple critical care variables will be predictive of both sensorimotor and autonomic outcomes, and susceptibility to infections at discharge and 6 and 12 mos after injury.
- Quantitative MRI indices of cord damage, and biomarkers of acute immune responses to injury will predict neurological outcomes at discharge and at 6 and 12 mos.
- The multivariate analysis of the constellation of acute variables and long-term outcome measures will yield new derived predictors of outcome that will facilitate stratification for clinical trials.
Specific Aims:
Aim 1. Diagnosis: Building a knowledge network for acute SCI. A detailed prospective study of critical care practices and outcomes for SCI patients admitted to TRACK-SCI sites will be conducted to build a knowledge network for acute SCI diagnostics.
Aim 2. Prognosis: Predictive models and biomarkers. The research team will develop multidimensional prognostic indicators for predicting outcomes and stratifying patients using detailed physiological, imaging, and genetic datasets.
Aim 3: Data analysis and sharing. The development of better predictors of outcome and methods for stratification will be advanced by allowing qualified access to our granular data. The availability to qualified users of the detailed acute 'diagnostic' dataset along with gene-expression data and functional outcomes at 6\&12 mos will leverage the project as a valuable international SCI community resource.
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Biomarkers, Neuroimaging, NINDS Common Data Elements, Spine Injury, Neurosurgery, Neurology
- Medical subject headings
- Spinal Cord Injuries, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From admission to 12 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start14 May 2015
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, The Craig H. Neilsen Foundation, Wings for Life
- Responsible party
- Sponsor
- Investigators
- Michael S Beattie, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565366
- Sponsor's protocol ID
- SC150198
- Other IDs
- W81XWH-16-1-0497
- Acronym
- TRACK-SCI
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2020
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data (de-identified) that underlie results in a publication will be made available to other researchers upon Executive Committee approval. Select de-identified datasets will be made publicly available via the Open Data Commons for Spinal Cord Injury (ODC-SCI), accessible at \<https://scicrunch.org/odc-sci\>.
Publications
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.
PubMed 26161519Burke 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.
PubMed 30496474Tsolinas 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.
PubMed 32357323Dhall 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.
PubMed 28973360McCoy 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.
PubMed 30923086
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Critical Care Decisions and Outcomes After SCI: TRACK-SCI
- ClinicalTrials.gov ID
- NCT04565366
- Acronym / sponsor ID
- TRACK-SCI / SC150198
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Biomarkers, Neuroimaging, NINDS Common Data Elements, Spine Injury, Neurosurgery, Neurology
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 726 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- United States Department of Defense, The Craig H. Neilsen Foundation, Wings for Life
- Study start
- 14 May 2015 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Spinal cord injury (SCI) is a major cause of morbidity worldwide with debilitating impacts on quality of life and the healthcare system. To date, a data-dense research registry specific to SCI remains to be constructed. To this end, the study will collect SCI data across five primary domains: 1) demographics and baseline history, 2) clinical course variables from the emergency department (ED) to the intensive care unit (ICU), 3) standard of care neuroimaging (CT and MRI) and intraoperative neuromonitoring, 4) blood and cerebrospinal fluid (CSF) samples for proteomic and genetic biomarkers, and 5) outcome measures of functional disability, mental health and quality of life at 3, 6, and 12 months. The investigators seek to correlate these high-density physiology data with baseline risk factors, imaging parameters, and biomarkers for a comprehensive approach to SCI diagnosis during acute care as well as prognosis across subacute and chronic phases of recovery -- in order to truly step toward the advancement of research and clinical knowledge in SCI.
The main objective is to provide a comprehensive prospective analysis of multiple variables in acute SCI that impact long-term outcomes. This is intended to provide a rich resource for asking key questions related to the optimization of treatment, and the planning and execution of pivotal clinical trials in SCI.
Core Hypotheses:
- Multiple critical care variables will be predictive of both sensorimotor and autonomic outcomes, and susceptibility to infections at discharge and 6 and 12 mos after injury.
- Quantitative MRI indices of cord damage, and biomarkers of acute immune responses to injury will predict neurological outcomes at discharge and at 6 and 12 mos.
- The multivariate analysis of the constellation of acute variables and long-term outcome measures will yield new derived predictors of outcome that will facilitate stratification for clinical trials.
Specific Aims:
Aim 1. Diagnosis: Building a knowledge network for acute SCI. A detailed prospective study of critical care practices and outcomes for SCI patients admitted to TRACK-SCI sites will be conducted to build a knowledge network for acute SCI diagnostics.
Aim 2. Prognosis: Predictive models and biomarkers. The research team will develop multidimensional prognostic indicators for predicting outcomes and stratifying patients using detailed physiological, imaging, and genetic datasets.
Aim 3: Data analysis and sharing. The development of better predictors of outcome and methods for stratification will be advanced by allowing qualified access to our granular data. The availability to qualified users of the detailed acute 'diagnostic' dataset along with gene-expression data and functional outcomes at 6\&12 mos will leverage the project as a valuable international SCI community resource.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene expression level in number of messenger RiboNucleic Acid (mRNA) transcripts for all genes expressed in white blood cells
Time frame: Baseline (healthy control group), or as close as possible to time of injury (SCI and trauma control group)
Obtained from a 4.0mL blood draw
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) (SCI Only)
Time frame: From admission to 12 months post-injury
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Background: PubMed 26161519Talbott 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.
- Background: PubMed 30496474Burke 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.
- Background: PubMed 32357323Tsolinas 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.
- Background: PubMed 28973360Dhall 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.
- Background: PubMed 30923086McCoy 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.
- Individual participant dataSharing planned: Yes. All data (de-identified) that underlie results in a publication will be made available to other researchers upon Executive Committee approval. Select de-identified datasets will be made publicly available via the Open Data Commons for Spinal Cord Injury (ODC-SCI), accessible at <https://scicrunch.org/odc-sci>.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael S Beattie, PhD principal investigator
University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by University of California, San Francisco at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression level in number of messenger RiboNucleic Acid (mRNA) transcripts for all genes expressed in white blood cells (time frame: Baseline (healthy control group), or as close as possible to time of injury (SCI and trauma control group)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04565366, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.