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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
No Placebo-Only Group

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 below
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My spinal injury is between my neck and lower back.
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I have a spinal cord injury with very limited or no movement in my legs.
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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 weeks
Treatment ~ Varies
Follow Up ~6 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,471 Previous Clinical Trials
2,489,524 Total Patients Enrolled
United States Department of DefenseFED
912 Previous Clinical Trials
334,256 Total Patients Enrolled
Brian Kwon, MDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

Near Infra-Red Spectroscopy (NIRS) Sensor (Optical Sensor) Clinical Trial Eligibility Overview. Trial Name: NCT04811235 — N/A
Spinal Cord Injury Research Study Groups: Arm 1
Spinal Cord Injury Clinical Trial 2023: Near Infra-Red Spectroscopy (NIRS) Sensor Highlights & Side Effects. Trial Name: NCT04811235 — N/A
Near Infra-Red Spectroscopy (NIRS) Sensor (Optical Sensor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04811235 — N/A
~3 spots leftby Dec 2025
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