Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial

NCT04811235 | Unknown

• 1 other identifier: H20-01259.
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (3)

• Safety Assessment - Neurologic Function

  6 Month

• Safety Assessment - Wound Assessment

  Day 7

• Safety Assessment - Adverse Events

  6 Months

Study Arms (1)

Arm 1

EXPERIMENTAL

NIRS monitoring of spinal cord oxygenation and hemodynamics

Device: Near Infra-Red Spectroscopy (NIRS) Sensor

Interventions

Near Infra-Red Spectroscopy (NIRS) Sensor DEVICE

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.

Arm 1

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• United States Department of Defense: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Brian Kwon, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Aludino

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 23, 2021
• Study Start: September 24, 2022
• Primary Completion: June 2, 2024
• Study Completion: September 30, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CA (1)