Using a new optical sensor to monitor spinal cord injuries
"OMNI-SCI" Trial - "Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury" Trial
This study is testing a new optical sensor that monitors blood and oxygen levels in patients with recent spinal cord injuries to see if it is safe and effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 17 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04811235 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel optical sensor that employs near-infrared spectroscopy (NIRS) technology to monitor oxygenation and hemodynamics in patients with acute spinal cord injuries. The sensor is placed over the dura after surgical decompression and collects real-time data for 7 days. The study aims to establish the safety, feasibility, and efficacy of this NIRS system in human participants, with a follow-up period of 6 months to assess outcomes. The research is being conducted at Vancouver General Hospital and involves 10 patients with specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 17 or older with acute traumatic spinal cord injuries between the bony levels C3 and L1.
Not a fit: Patients with isolated radiculopathy, cauda equina injuries, or spinal cord impairment due to tumors or infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could provide real-time monitoring of spinal cord health, potentially improving treatment outcomes for patients with spinal cord injuries.
How similar studies have performed: While this approach is novel in humans, promising preclinical data suggests that similar technologies have shown success in monitoring spinal cord conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vancouver, British Columbia
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Brian Kwon, MD — University of British Columbia
- Study coordinator: Allan Aludino
- Email: allan.aludino@vch.ca
- Phone: 604-875-4111 ext 61689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.