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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility Assessment - Overall
Feasibility Assessment: Sensor Application
Feasibility Assessment: Sensor Removal
Other outcome measures
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
1,418 Previous Clinical Trials
2,467,108 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,689 Total Patients Enrolled
Brian Kwon, MDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
144 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being accepted for this trial at the present time?
"According to the clinicaltrials.gov, this medical study is now actively sourcing participants for involvement in their research. The trail was first posted on September 24th 2022 and has been updated as recent as June 30th 2023."
Answered by AI
What is the current capacity of this research initiative?
"Affirmative. Clinicaltrials.gov portrays that this medical trial is now actively recruiting participants, with the initial post of September 24th 2022 and a recent update on June 30th 2023. The study requires 10 volunteers to be gathered at 1 site."
Answered by AI
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