Biomarkers of Spontaneous Recovery From Traumatic Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02731027|
Recruitment Status : Recruiting
First Posted : April 7, 2016
Last Update Posted : August 30, 2017
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|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
|Participants with Spinal Cord Injury|
- 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.
- 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.
- 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.
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.||firstname.lastname@example.org|
|Contact: Ashley Choryemail@example.com|
|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 firstname.lastname@example.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 email@example.com|
|Principal Investigator: Ona Bloom, Ph.D.|
|Principal Investigator:||Ona Bloom, Ph.D.||Northwell Health System|