Clinical trial NCT04811235: Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
Official title: "OMNI-SCI" Trial - "Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury" Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Spinal Cord Injury
Spinal Cord Injuries
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-03-23
Enrollment: 10
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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. 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. Our testing of this novel NIRS sensor in patients with acute SCI represents the first step in translating this technology for human use.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Feasibility Assessment - Overall
timeFrame: Day 7
measure: Feasibility Assessment: Sensor Application
timeFrame: Day 1
measure: Feasibility Assessment: Sensor Removal
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
measure: Safety Assessment - Neurologic Function
timeFrame: 6 Month
measure: Safety Assessment - Wound Assessment
timeFrame: Day 7
measure: Safety Assessment - Adverse Events
timeFrame: 6 Months
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brian Kwon, MD
role: PRINCIPAL_INVESTIGATOR
References: