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Optical Sensor
NIRS Monitoring for Spinal Cord Injury
N/A
Recruiting
Led By Brian Kwon, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Spinal cord impairment secondary to tumour, infection, epidural bleeding, or ischemia
Female patients who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
Summary
This trial tests a new device to measure oxygen & blood flow in the spinal cord of people with injuries, to help with treatment.
Who is the study for?
This trial is for men and women aged 17 or older with a non-penetrating spinal cord injury requiring surgery within 72 hours of the incident. Participants must have an injury between C3 and L1, be able to communicate in English, give consent, and not be pregnant. They should not have other medical conditions that make the trial unsafe.
What is being tested?
The study tests a new optical sensor using near-infrared spectroscopy (NIRS) on patients with acute spinal cord injuries. The NIRS sensor measures oxygenation and blood flow in the injured area during surgery to provide real-time data.
What are the potential side effects?
Since this is a monitoring device placed externally on the body, side effects are minimal but may include potential skin irritation at the site of application or discomfort from wearing the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal injury is between my neck and lower back.
Select...
I have a spinal cord injury with very limited or no movement in my legs.
Select...
I had surgery to stabilize my spine within 3 days after a non-penetrating spinal cord injury.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My spinal cord is affected due to a tumor, infection, bleeding, or lack of blood flow.
Select...
I am currently pregnant.
Select...
I have nerve pain or issues due to a specific spine injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility Assessment - Overall
Feasibility Assessment: Sensor Application
Feasibility Assessment: Sensor Removal
Other study objectives
Safety Assessment - Adverse Events
Safety Assessment - Neurologic Function
Safety Assessment - Wound Assessment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
NIRS monitoring of spinal cord oxygenation and hemodynamics
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,451 Previous Clinical Trials
2,483,180 Total Patients Enrolled
United States Department of DefenseFED
891 Previous Clinical Trials
332,468 Total Patients Enrolled
Brian Kwon, MDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
144 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My spinal injury is between my neck and lower back.My spinal cord is affected due to a tumor, infection, bleeding, or lack of blood flow.I am currently pregnant.I have a spinal cord injury with very limited or no movement in my legs.I am 17 years old or older.You have a recent injury that might make it hard for you to understand the study or affect how we measure your progress.I had surgery to stabilize my spine within 3 days after a non-penetrating spinal cord injury.You have any condition or injury that would make it hard to use or read the NIRS sensor.I have nerve pain or issues due to a specific spine injury.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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