Status:
UNKNOWN
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
United States Department of Defense
Conditions:
Acute Spinal Cord Injury
Spinal Cord Injuries
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
The study involves the 'first-in-human' evaluation of a novel optical sensor which uses near-infrared spectroscopy (NIRS) technology to assess oxygenation and hemodynamics of the injured spinal cord. ...
Detailed Description
This single-center, prospective observational study will enroll 10 patients admitted to Vancouver General Hospital (VGH) for treatment of an acute traumatic spine injury. Promising preclinical data d...
Eligibility Criteria
Inclusion
- Male or female aged 17 years or older
- Spinal injury between bony levels C3 and L1 inclusive
- Motor complete acute traumatic SCI (AIS A or B) or motor incomplete SCI (AIS C) with a total lower extremity motor score of less than 5
- Blunt (non-penetrating) SCI requiring posterior laminectomy with stabilization/fusion surgery within 72 hours of injury
- Able to communicate in English and provide informed consent
Exclusion
- Isolated radiculopathy or cauda equina injury
- Spinal cord impairment secondary to tumour, infection, epidural bleeding, or ischemia (in
- Any condition or injury (e.g. Morel-Lavellee lesion) that would interfere with the application or readings of the NIRS sensor
- Associated traumatic condition that would interfere with the informed consent process or outcome assessments (e.g. traumatic brain injury, pelvic, abdominal, or thoracic injuries)
- Any other medical condition that, in the investigator's opinion, would render the protocol procedures dangerous
- Female patients who are pregnant
Key Trial Info
Start Date :
September 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04811235
Start Date
September 24 2022
End Date
September 30 2024
Last Update
July 3 2023
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9