Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
NCT ID: NCT04811235
Last Updated: 2023-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2022-09-24
2024-09-30
Brief Summary
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Detailed Description
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Promising preclinical data demonstrates that the oxygenation and hemodynamic measures of our Near Infra-Red Spectroscopy (NIRS) system closely match the invasive intraparenchymal measures obtained within the injured spinal cord. Further, the NIRS sensor is responsive and reflective of systemic hemodynamic changes. This clinical protocol represents the first application of this novel NIRS sensor in human SCI. Following operative decompression of the spinal cord via a posterior approach, the NIRS sensor will be placed over the dura for 7 days to monitor spinal cord oxygenation and tissue hemodynamics. Patients will be followed for 6 months and data collection for safety, feasibly and efficacy of the NIRS System.
The specific aims of this project are to:
1. Establish the safety, feasibility, and efficacy of our NIRS system in monitoring tissue oxygenation and hemodynamics of the injured spinal cord in human participants.
2. Complete the technical refinement of the NIRS system utilizing an iterative process guided by participant recruitment and data accrual during the trial.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Arm 1
NIRS monitoring of spinal cord oxygenation and hemodynamics
Near Infra-Red Spectroscopy (NIRS) Sensor
The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time.
Interventions
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Near Infra-Red Spectroscopy (NIRS) Sensor
The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
17 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of British Columbia
OTHER
Responsible Party
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Brian Kwon
MD
Principal Investigators
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Brian Kwon, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H20-01259.
Identifier Type: -
Identifier Source: org_study_id
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