Acute Spinal Cord InjuryNCT04811235
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
A study testing Near Infra-Red Spectroscopy (NIRS) Sensor in people with Acute Spinal Cord Injury and Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Acute Spinal Cord Injury, Spinal Cord Injuries
- What is being tested?
- Near Infra-Red Spectroscopy (NIRS) Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 24 Sep 2022to 1 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "OMNI-SCI" Trial - "Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury" Trial
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.
Read the 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:
- Establish the safety, feasibility, and efficacy of our NIRS system in monitoring tissue oxygenation and hemodynamics of the injured spinal cord in human participants.
- 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
- Being tested
- Near Infra-Red Spectroscopy (NIRS) Sensor
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infra-Red Spectroscopy (NIRS) SensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | NIRS monitoring of spinal cord oxygenation and hemodynamics Receives: Device: Near Infra-Red Spectroscopy (NIRS) Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 7
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).
Measured: Day 1
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
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start24 Sep 2022
- Primary completion26 Oct 2022
- Study completion1 Apr 2026
Why it stopped: Following an SAE, a sensor refinement process was initiated. Although the SAE appears unrelated to the device, the refined sensor did not meet sensitivity/performance required for clinical use. It was deemed most appropriate to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Brian Kwon, University of British Columbia
- Investigators
- Brian Kwon, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811235
- Sponsor's protocol ID
- H20-01259.
- Other IDs
- CDMRP- SC200036
- Status last verified
- Jun 2023
- First submitted
- 15 Mar 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No