NIRS Monitoring for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen ByBrian Kwon, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of British Columbia

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My spinal injury is between my neck and lower back.

I have a spinal cord injury with very limited or no movement in my legs.

I had surgery to stabilize my spine within 3 days after a non-penetrating spinal cord injury.

Exclusion Criteria

My spinal cord is affected due to a tumor, infection, bleeding, or lack of blood flow.

I am currently pregnant.

I have nerve pain or issues due to a specific spine injury.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Arm 1Experimental Treatment1 Intervention

NIRS monitoring of spinal cord oxygenation and hemodynamics