Recruiting

Optical Monitoring

Sponsor:

University of British Columbia

Code:

NCT04811235

Conditions

Acute Spinal Cord Injury

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

Near Infra-Red Spectroscopy (NIRS) Sensor

Study Details

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.

Conditions

Acute Spinal Cord Injury

Spinal Cord Injuries

Study ID

NCT04811235

Start date

Sep 24, 2022

Status verified date

Jun, 2023

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Jun 2, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Arm 1

NIRS monitoring of spinal cord oxygenation and hemodynamics

Interventions

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.

Primary outcome measure

  • Feasibility Assessment - Overall [ Time Frame: Day 7 ]
  • Feasibility Assessment: Sensor Application [ Time Frame: Day 1 ]
  • Feasibility Assessment: Sensor Removal [ Time Frame: Day 7 ]

Central Contacts and Locations

Central contacts

Allan Aludino

604-875-4111 ext 61689allan.aludino@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Allan Aludino

604-875-4111allan.aludino@vch.ca

Principal Investigator:

Brian Kwon, MD, PhD

More Information

Sponsor

University of British Columbia

Last update posted

Jul 3, 2023

Last verified

Jun, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-07-03.