NCT04811235

Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial

"OMNI-SCI" Trial - "Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury" Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Spinal Cord Injury
• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-09-24
• Primary completion: 2024-06-02
• Completion: 2024-09-30
• First posted: 2021-03-23
• Last updated: 2023-07-03

Locations

1 site across 1 country: Canada