Spinal Cord InjurySCIMARKNCT02731027
Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Northwell Health at 6 sites in 2 countries.
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. 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 Injury
- How many people
- 42 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2015to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Ohio State University Medical Center
Columbus, Ohio, 43210
Frazier Rehab Institute, Univ. of Louisville
Louisville, Kentucky, 40202
The Feinstein Institute for Medical Research, Northwell Health
Manhasset, New York, 11030
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
Canada1 site
University of British Columbia
Vancouver, British Columbia, V5Z1M9
About this study
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord 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 |
|---|---|---|
| Healthy Controls | Not described | |
| Participants with Spinal Cord Injury | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 1 year
Secondary outcomes (2)
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, New York State Department of Health, University of Louisville, Kessler Foundation, Thomas Jefferson University, University of British Columbia, Ohio State University
- Responsible party
- Principal investigator, Ona Bloom, Northwell Health
- Investigators
- Ona Bloom, Ph.D., Principal investigator, Northwell Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731027
- Sponsor's protocol ID
- 14612
- Acronym
- SCIMARK
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2016
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02731027
- Acronym / sponsor ID
- SCIMARK / 14612
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- United States Department of Defense, New York State Department of Health, University of Louisville, Kessler Foundation, Thomas Jefferson University, University of British Columbia, Ohio State University
- Study start
- Oct 2015
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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 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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | – |
| Participants with 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 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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
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.
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.
2 secondary outcomes
Spinal Cord Independence Measure (SCIM) for each SCI participant
Time frame: 1 year
Neuromuscular Recovery Scale (NRS) for each SCI participant
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ona Bloom, Ph.D. principal investigator
Northwell Health System
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by Northwell Health at 6 sites in 2 countries.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Circulating inflammatory response from the peripheral blood for each SCI participant (time frame: 1 year). 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?
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 13 Nov 2020.