Near Infrared Spectroscopy for Stroke Prevention

Overseen By Jason Chui

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Disqualifiers: Skin lesions, Emergency surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of surgical procedure

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent brain injuries during shoulder surgery by using a new device called tr-fNIRS (Multi-channel Time-resolved Functional Near Infrared Spectroscopy). The device monitors the brain's oxygen levels to detect early signs of stroke, which can occur during or after surgery. Researchers believe certain brain areas might be more at risk of low oxygen and injury than others. Adults scheduled for elective shoulder surgery in a specific seated position under general anesthesia are good candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance surgical safety.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this optical device is safe for monitoring cerebral oxygenation during surgery?

Research has shown that Functional Near-Infrared Spectroscopy (fNIRS) is a safe and non-invasive tool, primarily used to monitor oxygen levels in the brain. Studies indicate that fNIRS is portable and can collect detailed brain information without causing harm. This technology, particularly the advanced multi-channel version, has been used in many medical settings. Reports of harmful effects from its use are absent, suggesting it is well-tolerated by patients. Although this study does not involve active treatment, using the device during surgery is unlikely to pose safety risks based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using multi-channel time-resolved functional near infrared spectroscopy (tr-fNIRS) during surgeries because it offers a new way to monitor brain health in real-time. Unlike traditional methods that might only measure general brain activity or require invasive procedures, tr-fNIRS provides detailed data on cerebral oxygenation in various brain regions without being intrusive. This technique could help prevent perioperative brain injuries by giving surgeons critical insights into brain oxygen levels, potentially improving patient outcomes during and after surgery.

What evidence suggests that this optical device is effective for monitoring cerebral oxygenation during surgery?

Research has shown that Multi-channel Time-resolved Functional Near Infrared Spectroscopy (tr-fNIRS) holds promise for monitoring brain health during surgery. This technology measures oxygen levels across various brain regions, not just a single area. Studies have found that it covers more of the brain and offers greater accuracy than traditional methods. Detecting low oxygen levels early is crucial, as these are linked to strokes during surgery. By identifying these changes, tr-fNIRS may help prevent brain injuries by spotting problems before they become serious. In this trial, the tr-fNIRS neuromonitor will be used during shoulder surgery to gather data on cerebral oxygenation across multiple brain regions, although no intervention will be based on the results. ^{3 6 7 8 9}

Who Is on the Research Team?

Jason Chui

Principal Investigator

Western University

Are You a Good Fit for This Trial?

Inclusion Criteria

Scheduled to have elective shoulder surgery in the beach-chair position under general anesthesia

Provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

tr-fNIRS is used to monitor regional brain oxygenation from anesthesia induction to completion of surgery

Duration of surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of covert stroke and neurological deficits

Up to 72 hours following surgery or until discharge from hospital

What Are the Treatments Tested in This Trial?

Interventions

• Multi-channel Time-resolved Functional Near Infrared Spectroscopy

How Is the Trial Designed?

Group I: tr-FNIRS neuromonitor Experimental Treatment 1 Intervention

During shoulder surgery, the tr-fNIRS (time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)) neuromonitor will be used to gather data on cerebral oxygenation of multiple brain regions for these patients. No intervention will be administered based on the results of the tr-fNIRS.

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Citations

1. opg.optica.org opg.optica.org/oe/fulltext.cfm?uri=oe-14-12-5418

Multi-channel time-resolved system for functional near ... We have designed a compact dual wavelength multi-channel time-resolved system for functional near infrared spectroscopy. The system enables 16 sources and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05752981

Multi-channel Time-resolved Functional Near Infrared ... In this study, the investigators plan to apply a cutting-edge optical device, tr-fNIRS, to monitor the whole brain during shoulder surgery. The primary aim is ...

3. trialx.com trialx.com/clinical-trials/listings/323476/multi-channel-time-resolved-functional-near-infrared-spectroscopy-for-prevention-of-perioperative-brain-injury/?&radius=50

Multi-channel Time-resolved Functional Near Infrared ... The primary aim is to determine any regional differences in cerebral oxygenation (ScO2) and cerebral autoregulation (CA)between brain regions ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7364176/

Functional Near-Infrared Spectroscopy and Its Clinical ... Multichannel NIRS has improved the spatial resolution of fNIRS for brain mapping in certain task modalities, such as language mapping. However, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667242125000922

Near-infrared time-resolved spectroscopy reveals task ... Near-infrared time-resolved spectroscopy reveals task-induced emotions by measuring cerebral blood oxygenation changes in the frontal pole during creative ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9982178/

Functional Near-Infrared Spectroscopy as a Personalized ... The first major trend is multimodal monitoring using fNIRS, which allows clinicians to access more data that will help them to understand the ...

7. mdpi.com mdpi.com/2076-3425/11/5/606

Data Processing in Functional Near-Infrared Spectroscopy ... The purpose of this review is to provide a guide on fNIRS pre-processing and processing techniques pertinent to the field of human motor control research.

8. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2020.00724/full

Functional Near-Infrared Spectroscopy and Its Clinical ... Multichannel NIRS has improved the spatial resolution of fNIRS for brain mapping in certain task modalities, such as language mapping. However, ...

9. sciencedirect.com sciencedirect.com/topics/neuroscience/functional-near-infrared-spectroscopy

Functional near Infrared Spectroscopy - an overview Functional near-infrared spectroscopy is a neuroimaging technology that is non-invasive, portable, and repeatable, used for monitoring cerebral oxygenation in ...