"OMNI-SCI" Trial - "Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury" Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility Assessment: Sensor Application
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility Assessment: Sensor Application
时间窗: Day 1
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).
Feasibility Assessment - Overall
时间窗: Day 7
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
Feasibility Assessment: Sensor Removal
时间窗: Day 7
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
次要结局
未报告次要终点
研究者
Brian Kwon
MD
University of British Columbia