Spinal Cord Injuries Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | United States Department of Defense |
Canada,
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 |
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