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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04811235
• Other study ID #: H20-01259.
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2023
• Source: University of British Columbia
• Contact: Allan Aludino
• Phone: 604-875-4111 ext 61689
• Email: allan.aludino[@]vch.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 30, 2024
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	United States Department of Defense

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Assessment - Neurologic Function	Neurologic function will be assessed using the International Standards for Neurologic Classification of Spinal Cord Injury (ISNCSCI) to determine if the application, 7-day placement, or removal of the NIRS sensor is associated with any deterioration in spinal cord function.	6 Month
Other	Safety Assessment - Wound Assessment	The externalization of a foreign body may lead to an increased risk of surgical site infection. Any incidence of wound infection will be monitored and document on a wound assessment form.	Day 7
Other	Safety Assessment - Adverse Events	The incidence of AEs in the acute SCI patient population is significant. For the purposes of this study, and in keeping with standard of care on the Acute Spine Unit at study site, all AEs will be recorded utilizing the Spine Adverse Event (SAVES) form, a well-established system for prospectively documenting AEs in spine patients	6 Months
Primary	Feasibility Assessment - Overall	Study specific questionnaire will collected data on the the ease of sensor application, NIRS monitoring and sensor removal is recorded with this form. Series of questions requiring the assessment of the NIRS system using yes/no and 10-point scoring scale	Day 7
Primary	Feasibility Assessment: Sensor Application	Study specific form will be used record data associated with application of the NIRS sensor, such as the laminectomy and instrumentation data, location of the sensor and ease of application (score out of 10).	Day 1
Primary	Feasibility Assessment: Sensor Removal	Study specific form will be used to record the condition of the sensor and participants' experience (score out of 10) at the time of sensor removal	Day 7